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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-08660 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20-134 | |||
| 10313 | Other Identifier | UPMC Hillman Cancer Center LAO | |
| 10313 | Other Identifier | CTEP | |
| UM1CA186690 | U.S. NIH Grant/Contract | View source |
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This phase Ib/II trial studies the best dose of carboplatin when given together with berzosertib, gemcitabine and pembrolizumab and to see how well it works in treating patients with stage IV squamous cell non-small cell lung cancer that has spared to other placed in the body (advanced). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving berzosertib together with carboplatin, gemcitabine, and pembrolizumab may work better in treating patients with squamous cell non-small cell lung cancer compared to carboplatin, gemcitabine, and pembrolizumab alone.
PRIMARY OBJECTIVES:
I. To determine the recommended phase 2 dose (RP2D) of carboplatin in combination with berzosertib (M6620) and gemcitabine/pembrolizumab, in patients with squamous cell non-small cell lung cancer (Sq-NSCLC). (Lead-in Phase 1B) II. To compare progression-free survival (PFS) of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970) in patients with Sq-NSCLC, as measured by a hazard ratio in an intent-to-treat analysis. (Phase 2)
SECONDARY OBJECTIVES:
I. To compare progression-free survival (PFS) of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970) in patients with Sq-NSCLC, as measured by a hazard ratio in an as-treated analysis.
II. To compare PFS of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970) in patients with ataxia telangiectasia mutated (ATM)-deficient Sq-NSCLC, as measured by a hazard ratio.
III. To compare overall survival (OS) and overall response rate (ORR) of carboplatin/gemcitabine/pembrolizumab with and without berzosertib (M6620, VX-970), in patients with chemotherapy-naive Sq-NSCLC.
IV. To determine the systemic drug exposure of berzosertib (M6620, VX-970) and gemcitabine, as correlates of efficacy and toxicity.
V. To determine the safety and tolerability of berzosertib (M6620, VX-970) in combination with carboplatin/gemcitabine/pembrolizumab.
VI. To observe and record anti-tumor activity.
EXPLORATORY OBJECTIVES:
I. To identify molecular subpopulations of patients who have increased sensitivity to the berzosertib (M6620, VX-970)/carboplatin/gemcitabine/pembrolizumab combination.
II. To explore the prognostic and predictive qualities of the ATM immunohistochemistry (IHC) assay for clinical response and PFS.
III. To explore inflammation-associated gene signatures and clinical response.
OUTLINE: This is a phase Ib, dose de-escalation study of carboplatin followed by a phase II study. Patients are randomized to 1 of 2 arms.
ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and berzosertib IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab IV over 30 minutes on day 1 and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab alone IV over 30 minutes on day 1. Cycles repeat every 6 weeks for up to 1 more year in the absence of disease progression or unacceptable toxicity. Patients undergo magnetic resonance imaging (MRI) scans and/or computed tomography (CT) scans, and undergo blood specimen collection on study.
ARM B: Patients receive pembrolizumab, gemcitabine hydrochloride, and carboplatin as in Arm A. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study.
After completion of study treatment, patients are followed up every 3 months for 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (pembrolizumab, gemcitabine, carboplatin, M6620) | Experimental | Patients receive pembrolizumab IV over 30 minutes on day 1, gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, carboplatin IV over 30 minutes on day 1, and berzosertib IV over 60 minutes on days 2 and 9. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab IV over 30 minutes on day 1 and berzosertib IV over 60 minutes on days 2 and 9. Cycles repeat every 21 days for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients then receive pembrolizumab alone IV over 30 minutes on day 1. Cycles repeat every 6 weeks for up to 1 more year in the absence of disease progression or unacceptable toxicity. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study. |
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| Arm B (pembrolizumab, gemcitabine, carboplatin) | Active Comparator | Patients receive pembrolizumab, gemcitabine, and carboplatin as in Arm A. Patients undergo MRI scans and/or CT scans, and undergo blood specimen collection on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berzosertib | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients Who Experienced a DLT | Percentage of patients who experienced Dose Limiting Toxicities (DLTs) when treated with carboplatin in combination with berzosertib (M6620, VX-970), per CTCAE v5.0 | Up to completion of cycle 1 |
| Recommended Phase 2 Dose (RP2D) | Determined by the number of patients who experienced Dose Limiting Toxicities (DLTs) when treated with carboplatin in combination with berzosertib (M6620, VX-970), per CTCAE v5.0, DLT is defined as the severe toxicity event that leads to the termination of the treatment. The RP2D is the highest dose level where <2/6 DLTs are observed. | Up to completion of cycle 1 |
| 12-month Progression-free Survival (PFS) - Total Population | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | At 12 months |
| 24-month Progression-free Survival (PFS) - Total Population | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response - Total Population | Percentage of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Measure | Description | Time Frame |
|---|---|---|
| Determination if Features of Whole Exome and Ribonucleic Acid (RNA) Sequencing Are Predictive OR, OS, or PFS | Sparse modeling (e.g., the lasso) will be used to determine if any features of whole exome and RNA sequencing are predictive of OR, OS or PFS. | Up to 12 months post treatment |
| ATM Assay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liza C Villaruz | University of Pittsburgh Cancer Institute LAO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medicine of USC Koreatown | Los Angeles | California | 90020 | United States | ||
| Los Angeles General Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41206673 | Derived | Villaruz LC, Schluger B, Wang H, Ohr J, Petro D, Fuld AD, Herzberg B, Dawar R, Nieva J, Ruiz J, Christner SM, Holleran JL, Bakkenist CJ, Gore S, Beumer JH. Phase Ib study of berzosertib, carboplatin, gemcitabine, and pembrolizumab in patients with squamous nonsmall lung cancer (ETCTN 10313). Oncologist. 2025 Nov 11;30(11):oyaf373. doi: 10.1093/oncolo/oyaf373. |
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NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level -1 (Pembrolizumab, Gemcitabine, Carboplatin, M6620) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - 4 AUC Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2024 |
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| Biospecimen Collection | Procedure | Correlative studies |
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| Carboplatin | Drug | Given IV |
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| Computed Tomography | Procedure | Undergo CT |
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| Gemcitabine Hydrochloride | Drug | Given IV |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
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| Pembrolizumab | Biological | Given IV |
|
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| At 24 months |
| Progression-free Survival (PFS) - Total Population | Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Up to 30 months |
| 12-month Progression-free Survival (PFS) - By Dose Level | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | At 12 months |
| 24-month Progression-free Survival (PFS) - Dose Level 1 | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | At 24 months |
| Progression-free Survival (PFS) - By Dose Level | Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Up to 30 months |
| Up to 12 months post treatment |
| Best Overall Response - By Dose Level | Percentage of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Up to 12 months post treatment |
| 12-month Overall Survival (OS) - Total Population | Percentage of patients alive from start of treatment. | At 12 months |
| 24-month Overall Survival (OS) - Total Population | Percentage of patients alive from start of treatment. | At 24 months |
| Overall Survival (OS) - Total Population | Median number of months that patients remain alive from start of treatment. | Up to 30 months post treatment |
| 12-month Overall Survival (OS) - By Dose Level | Percentage of patients alive from start of treatment. | At 12 months |
| 24-month Overall Survival (OS) - By Dose Level | Percentage of patients alive from start of treatment. | At 24 months |
| Overall Survival (OS) - By Dose Level | Median number of months that patients remain alive from start of treatment. | Up to 30 months post treatment |
| Worst Grade of Adverse Events | Number of patients with adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, determined to be at least possibly related to treatment. | Up to 12 months post treatment |
| PFS in Ataxia Telangiectasia Mutated (ATM)-Deficient Sq-NSCLC | Progression Free Survival in ataxia telangiectasia mutated (ATM)-deficient Sq-NSCLC. Median PFS estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Up to 30 months |
Proportional hazards (Cox) regression will be used to assess the relationship between the ATM assay and OS and PFS. |
| Up to 12 months post treatment |
| Inflammation-associated Gene Signatures | Logistic regression and proportional hazards (Cox) regression will be used to explore the relationship between inflammation-associated gene signatures and OR, OS, and PFS. | Up to 12 months post treatment |
| Los Angeles |
| California |
| 90033 |
| United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| USC Norris Oncology/Hematology-Newport Beach | Newport Beach | California | 92663 | United States |
| UM Sylvester Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | United States |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | United States |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | United States |
| HaysMed | Hays | Kansas | 67601 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | United States |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | United States |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | United States |
| Mercy Hospital Pittsburg | Pittsburg | Kansas | 66762 | United States |
| Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| University of Kansas Health System Saint Francis Campus | Topeka | Kansas | 66606 | United States |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | United States |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | United States |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | United States |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | United States |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Wake Forest University at Clemmons | Clemmons | North Carolina | 27012 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232 | United States |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | United States |
| FG001 | Dose Level 1 (Pembrolizumab, Gemcitabine, Carboplatin, M6620) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - 5 AUC Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
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| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lead-in Dose Level -1 (Pembrolizumab, Gemcitabine, Carboplatin, M6620) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - 4 AUC Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
|
| BG001 | Lead-in Dose Level 1 (Pembrolizumab, Gemcitabine, Carboplatin, M6620) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - 5 AUC Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
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| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ECOG Performance Score | 0 Fully active, able to carry on all pre-disease performance without restriction
| Number | Score on a scale |
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| Tumor Type - Squamous cell lung cancer | Count of Participants | Participants |
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| Patients with Zero Prior Lines of Therapy for Advanced Disease | Number of patients who received none/zero (0) lines of systemic chemotherapy for metastatic disease. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patients Who Experienced a DLT | Percentage of patients who experienced Dose Limiting Toxicities (DLTs) when treated with carboplatin in combination with berzosertib (M6620, VX-970), per CTCAE v5.0 | Treated patients evaluated for Dose Limiting Toxicities (DLTs) | Posted | Number | 95% Confidence Interval | percentage of patients | Up to completion of cycle 1 |
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| Primary | Recommended Phase 2 Dose (RP2D) | Determined by the number of patients who experienced Dose Limiting Toxicities (DLTs) when treated with carboplatin in combination with berzosertib (M6620, VX-970), per CTCAE v5.0, DLT is defined as the severe toxicity event that leads to the termination of the treatment. The RP2D is the highest dose level where <2/6 DLTs are observed. | Treated patients evaluated for Dose Limiting Toxicities (DLTs) who received Dose Level -1 (carboplatin dosed at 4 mg/mL*min) | Posted | Number | mg/mL*min | Up to completion of cycle 1 |
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| Primary | 12-month Progression-free Survival (PFS) - Total Population | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients evaluated for radiologic response. | Posted | Number | 95% Confidence Interval | percentage of patients | At 12 months |
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| Primary | 24-month Progression-free Survival (PFS) - Total Population | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients evaluated for radiologic response. | Posted | Number | 95% Confidence Interval | percentage of patients | At 24 months |
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| Primary | Progression-free Survival (PFS) - Total Population | Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients evaluated for radiologic response. | Posted | Median | 95% Confidence Interval | months | Up to 30 months |
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| Primary | 12-month Progression-free Survival (PFS) - By Dose Level | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients who were radiologically evaluable. | Posted | Number | 95% Confidence Interval | percentage of patients | At 12 months |
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| Primary | 24-month Progression-free Survival (PFS) - Dose Level 1 | Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients who were radiologically evaluable. | Posted | Number | 95% Confidence Interval | percentage of patients | At 24 months |
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| Primary | Progression-free Survival (PFS) - By Dose Level | Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients who were radiologically evaluable. | Posted | Median | 95% Confidence Interval | months | Up to 30 months |
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| Secondary | Best Overall Response - Total Population | Percentage of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients evaluated for radiologic response. | Posted | Number | 95% Confidence Interval | percentage of patients | Up to 12 months post treatment |
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| Secondary | Best Overall Response - By Dose Level | Percentage of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Treated patients evaluated for radiologic response. | Posted | Number | percentage of patients | Up to 12 months post treatment |
| |||||||||||||||||||||||||||||||
| Secondary | 12-month Overall Survival (OS) - Total Population | Percentage of patients alive from start of treatment. | All treated patients | Posted | Number | 95% Confidence Interval | percentage of patients | At 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | 24-month Overall Survival (OS) - Total Population | Percentage of patients alive from start of treatment. | All treated patients | Posted | Number | 95% Confidence Interval | percentage of patients | At 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - Total Population | Median number of months that patients remain alive from start of treatment. | All treated patients. | Posted | Median | 95% Confidence Interval | months | Up to 30 months post treatment |
|
| |||||||||||||||||||||||||||||
| Secondary | 12-month Overall Survival (OS) - By Dose Level | Percentage of patients alive from start of treatment. | All treated patients | Posted | Number | 95% Confidence Interval | percentage of patients | At 12 months |
| ||||||||||||||||||||||||||||||
| Secondary | 24-month Overall Survival (OS) - By Dose Level | Percentage of patients alive from start of treatment. | All treated patients. | Posted | Number | 95% Confidence Interval | percentage of patients | At 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) - By Dose Level | Median number of months that patients remain alive from start of treatment. | All treated patients. | Posted | Median | 95% Confidence Interval | months | Up to 30 months post treatment |
| ||||||||||||||||||||||||||||||
| Secondary | Worst Grade of Adverse Events | Number of patients with adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, determined to be at least possibly related to treatment. | Treated patients who experienced adverse events. | Posted | Count of Participants | Participants | Up to 12 months post treatment |
| |||||||||||||||||||||||||||||||
| Secondary | PFS in Ataxia Telangiectasia Mutated (ATM)-Deficient Sq-NSCLC | Progression Free Survival in ataxia telangiectasia mutated (ATM)-deficient Sq-NSCLC. Median PFS estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | Did not proceed with phase II of the study; no patient tumors were tested for ATM deficiency as planned | Posted | Up to 30 months |
|
| ||||||||||||||||||||||||||||||||
| Other Pre-specified | Determination if Features of Whole Exome and Ribonucleic Acid (RNA) Sequencing Are Predictive OR, OS, or PFS | Sparse modeling (e.g., the lasso) will be used to determine if any features of whole exome and RNA sequencing are predictive of OR, OS or PFS. | Not Posted | Up to 12 months post treatment | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | ATM Assay | Proportional hazards (Cox) regression will be used to assess the relationship between the ATM assay and OS and PFS. | Not Posted | Up to 12 months post treatment | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Inflammation-associated Gene Signatures | Logistic regression and proportional hazards (Cox) regression will be used to explore the relationship between inflammation-associated gene signatures and OR, OS, and PFS. | Not Posted | Up to 12 months post treatment | Participants |
Adverse Events data were collected for 2 years, 11 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level -1 (Pembrolizumab, Gemcitabine, Carboplatin, M6620) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - 4 AUC Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
| 2 | 6 | 6 | 6 | 6 | 6 |
| EG001 | Dose Level 1 (Pembrolizumab, Gemcitabine, Carboplatin, M6620) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - 5 AUC Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
| 6 | 6 | 5 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastric hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Pancytopenia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arterial thromboembolism | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hemoptysis | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vision decreased | Eye disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cecal hemorrhage | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Heartburn | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| dry heaves | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| body aches | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Thrush | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| INR increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Thyroid stimulating hormone increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| increased LDH | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| thrombocytopenia | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperlipidemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Extracranial Vascular Stenosis | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Movements involuntary | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pressure Left eye | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Transient ischemic attacks | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Creatinine clearance decrease | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Elevated Creatinine | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Urine Retention | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hoarseness | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus pressure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stadterman, MPH, MSCCR, CCRP, Clinical Research Manager | UPMC Hillman Cancer Center | 4126475554 | stadtermanbm@upmc.edu |
| Jun 27, 2025 |
| Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: P10313_A15PhaseIIConsent(Untracked) | Nov 5, 2024 | Apr 2, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598331 | berzosertib |
| D013048 | Specimen Handling |
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D009682 | Magnetic Resonance Spectroscopy |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| ECOG = 1 |
|
|
|
|
|
|
|
|
| OG001 | Dose Level 1 (Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - AUC of 5 mg/mL•min Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
|
|
|
|
|
| OG001 | Dose Level 1 (Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - AUC of 5 mg/mL•min Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
|
|
|
|
|
| OG001 | Dose Level 1 (Berzosertib (M6620) + Carboplatin + Gemcitabine + Pembrolizumab) | Chemotherapy-naïve patients expected to tolerate higher doses of platinum chemotherapy. Berzosertib: Given IV - 135 mg/m2 Carboplatin: Given IV - AUC of 5 mg/mL•min Gemcitabine Hydrochloride: Given IV - 800 mg/m2 Pembrolizumab: Given IV - 200 mg The following treatment schedule will be used for a total of two years of treatment. Pembrolizumab administration should not exceed 2 years.
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