Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024 511007 41 00 | EU Trial (CTIS) Number | ||
| U1111-1312-8770 | Other Identifier | Universal Trial Number |
Not provided
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Lack of efficacy
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The primary purpose of this study is to determine the safety and tolerability of the combination of bemcentinib with chemo-immunotherapy (CIT) to identify the recommended phase 2 dose (RP2D) when administered as first line (1L) treatment in participants with locally advanced (Stage IIIb/IIIC) or metastatic (Stage IV) non-squamous NSCLC with no actionable mutations and to determine the anti-tumor activity of the combination of bemcentinib with CIT when administered as 1L treatment in participants with locally advanced (Stage IIIb/IIIc) or metastatic (Stage IV) non-squamous NSCLC with serine/threonine kinase 11 (STK11) mutation and no actionable mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b Cohort 1: Bemcentinib 75 mg | Experimental | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 75 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). |
|
| Phase 1b Cohort 2: Bemcentinib 100 mg | Experimental | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 100 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). |
|
| Phase 1b Cohort 3: Bemcentinib 150 mg | Experimental | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 150 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). |
|
| Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemcentinib | Drug | Bemcentinib capsules will be administered daily orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) | DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment. | Cycle 1 (the first 21 days of treatment) |
| Phase 2a: Objective Response Rate (ORR) at 6 Months | ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1. | 6 months |
| Phase 2a: Objective Response Rate (ORR) at 12 Months | ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1. | 12 months |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States | ||
| University of Chicago |
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Participants were screened to the inclusion/exclusion criteria of the protocol. The following assessments were performed: Informed Consent, Demographics, Medical/Surgical History including NSCLC diagnosis and prior anticancer treatments, Pregnancy/FSH, ECOG performance score, Vital signs, Physical examination, Echocardiogram, Laboratory Safety Testing, ECG, Tumour imaging/sampling and biopsies & blood sampling for genomic DNA/serum biomarkers.
Study recruitment was undertaken across 7 planned countries: USA, France, Greece, Hungary, Italy, Poland & Spain. Of these countries, 5 countries enrolled participants: USA (10 participants), France (5 participants), Greece (3 participants), Italy (2 participants) & Spain (6 participants). The recruitment process began in March 2023 and concluded in February 2025. 65 participants were screened in order to successfully recruit 26 participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1b Cohort 1: Bemcentinib 75 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 75 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). Bemcentinib: Bemcentinib capsules will be administered daily orally. Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks. Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks. Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| 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 | Jul 7, 2023 |
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| Experimental |
Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib second dose, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). |
|
| Pembrolizumab | Drug | Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks. |
|
| Pemetrexed | Drug | Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks. |
|
| Carboplatin | Drug | Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days. |
|
| Chicago |
| Illinois |
| 60637 |
| United States |
| Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Duke University Medical Center - Duke Cancer Center | Durham | North Carolina | 27710 | United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Hôpital prive du Confluent SAS, Departement d'oncologie | Nantes | 44277 | France |
| Centre Antoine Lacassagne | Nice | 6189 | France |
| Hôpital Europeen Georges Pompidou (HEGP), Service de cancérologie | Paris | 75015 | France |
| Institut Gustave Roussy, Service de médecine | Villejuif | 94805 | France |
| Henry Dunant Hospital Center, 4th Oncology Department | Athens | 115 26 | Greece |
| Sotiria General Hospital of Chest Diseases, 3rd Department of Internal Medicine, Oncology Unit | Athens | 115 27 | Greece |
| General Hospital of Athens Alexandra, Department of the Clinical Therapeutics, Medical Oncology Unit | Athens | 11528 | Greece |
| University General Hospital of Larissa, Oncology Clinic | Larissa | 41110 | Greece |
| Semmelweis University- Department of Pulmonology | Budapest | 1083 | Hungary |
| Orszagos Koranyi Pulmonologiai Intezet | Budapest | 1121 | Hungary |
| Fejer County St. Gyorgy Hospital | Székesfehérvár | 8000 | Hungary |
| Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi | Bologna | 40138 | Italy |
| Ospedale San Luca | Lucca | 55100 | Italy |
| IRCCS - Istituto Europeo di Oncologia IEO | Milan | 20141 | Italy |
| IFO Regina Elena | Rome | 144 | Italy |
| Uniwersytecki Szpital Kliniczny w Bialymstoku, II Klinika Chorob Pluc, raka płuca i chorób wewnętrznych | Bialystok | 15-540 | Poland |
| Instytut Centrum Zdrowia Matki Polki (ICZMP) | Lodz | 93-338 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie | Lublin | 20090 | Poland |
| MedPolonia Sp z oo | Poznan | 60693 | Poland |
| Hospital Universitari Germans Trias i Pujol | Badalona | 8916 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 8035 | Spain |
| MD Anderson Cancer Center, Oncology service | Madrid | 28033 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Fundacion Instituto Valenciano de Oncologia (FIVO) | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| FG001 | Phase 1b Cohort 2: Bemcentinib 100 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 100 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). Bemcentinib: Bemcentinib capsules will be administered daily orally. Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks. Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks. Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days. |
| FG002 | Phase 1b Cohort 3: Bemcentinib 150 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations will receive bemcentinib 150 mg once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). Bemcentinib: Bemcentinib capsules will be administered daily orally. Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks. Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks. Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days. |
| FG003 | Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the dose determined from Phase 1b) | Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). Bemcentinib: Bemcentinib capsules will be administered daily orally. Pembrolizumab: Pembrolizumab will be administered as an intravenous (IV) infusion as part of CIT every 3 weeks. Pemetrexed: Pemetrexed will be administered as an IV infusion as part of CIT every 3 weeks. Carboplatin: Carboplatin will be administered as an IV infusion as part of CIT every 3 weeks up to 4 cycles. Each cycle = 21 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
This analysis population includes all 26 enrolled participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b Cohort 1: Bemcentinib 75 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. |
| BG001 | Phase 1b Cohort 2: Bemcentinib 100 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. |
| BG002 | Phase 1b Cohort 3: Bemcentinib 150 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. |
| BG003 | Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b) | Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Weight | Median | Full Range | Kilograms |
| |||||||||||||||
| Height | Median | Full Range | Centimetres |
|
| 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 | Phase 1b: Number of Participants With Dose Limiting Toxicity (DLT) | DLT graded using NCI CTCAE Version 5.0 based on the Investigator assessment. | This analysis population included all 10 participants who were enrolled into Phase 1b of the study and completed at least one cycle of treatment for evaluation of DLT. | Posted | Count of Participants | Participants | Cycle 1 (the first 21 days of treatment) |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Phase 2a: Objective Response Rate (ORR) at 6 Months | ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1. | This analysis population included all 16 participants who were enrolled into Phase 2a of the study and completed sufficient cycles of treatment up to the 6-month timepoint. | Posted | Count of Participants | Participants | 6 months |
|
| |||||||||||||||||||||||||||||||||
| Primary | Phase 2a: Objective Response Rate (ORR) at 12 Months | ORR is defined as percentage of participants with complete response and partial response per RECIST 1.1. | This analysis population included all 16 participants who were enrolled into Phase 2a of the study and completed sufficient cycles of treatment up to the 12-month timepoint. | Posted | Count of Participants | Participants | 12 months |
|
|
Adverse event data were collected from ICF signing until 30 days post the last treatment on study (approximately 1 year).
All reported adverse events were mapped to standard MedDRA coding terms, grouped by system organ class and preferred term and tabulated by treatment cohorts.
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 | Phase 1b Cohort 1: Bemcentinib 75 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 75 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Phase 1b Cohort 2: Bemcentinib 100 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 100 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. | 1 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Phase 1b Cohort 3: Bemcentinib 150 mg | Participants with previously untreated locally advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC without actionable mutations received oral bemcentinib 150 mg once daily until a reason for discontinuation had been met or for up to 2 years, whichever occurred first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. | 3 | 4 | 1 | 4 | 4 | 4 |
| EG003 | Phase 2a Expansion Cohort: Bemcentinib 100 mg (as the Dose Determined From Phase 1b) | Participants with previously untreated advanced (Stage IIIb/IIIc)/metastatic (Stage IV) non-squamous NSCLC having a serine/threonine kinase 11 (STK11) mutation as identified by Next Generation Sequencing (NGS) and without actionable mutations will receive bemcentinib, at RP2D identified in Phase 1b, once daily until a reason for discontinuation has been met or for up to 2 years, whichever occurs first along with CIT (pembrolizumab infusion followed by pemetrexed and carboplatin). CIT was administered on day 1 of 21-day cycles via intravenous (IV) infusions and comprised pembrolizumab, pemetrexed, and carboplatin. Carboplatin was administered for a maximum of 4 cycles only. | 6 | 16 | 6 | 16 | 15 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Claudication in Peripheral Vascular Disease | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment | Intermittent Claudication |
|
| Embolic Stroke | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment | Pyelonephritis E.coli Urinary Tract Infection |
|
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Platelets Count Decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Weight Loss | Investigations | MedDRA (27.1) | Non-systematic Assessment | Weight Decreased |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Mucositis | General disorders | MedDRA (27.1) | Non-systematic Assessment | Mucosal Inflammation |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Upper Digestive Bleeding | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment | Upper Gastrointestinal Haemorrhage |
|
| Enterococcus Faecalis Infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Epigastralgia | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment | Abdominal Pain Upper |
|
| Secondary Adrenal Insufficiency | Endocrine disorders | MedDRA (27.1) | Non-systematic Assessment | Secondary Adrenocortical Insufficiency |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| White Blood Cells Decrease | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Atrial Fibrillation With RVR | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bowel Perforation | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thrombolic Event - Right Ventricle | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment | Embolism |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine Aminotransferase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dry Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dyspnea on Exertion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Erythematous Lesions of the Anterior Face, Torso and Dorsal Root and Legs, Pruritic | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment | Erythema |
|
| Fatigue | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA (27.1) | Non-systematic Assessment | Pyrexia |
|
| Inappetence | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment | Decreased Appetite |
|
| Large Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Acid Reflux | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment | Gastrooesophageal Reflux Disease |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bilateral Leg Pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment | Pain in Extremity |
|
| Claudication in Peripheral Vascular Disease | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment | Intermittent Claudication |
|
| Constipation | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hand Itching | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment | Pruritus |
|
| Head Pain | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment | Headache |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Short of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment | Dyspnoea |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Swollen Legs | General disorders | MedDRA (27.1) | Non-systematic Assessment | Peripheral Swelling |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Embolic Stroke | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment | Embolic Stroke |
|
| Feeling Frail | General disorders | MedDRA (27.1) | Non-systematic Assessment | Asthenia |
|
| Generalised Pain | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pelvic Pain | Reproductive system and breast disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Urinary Frequency | Renal and urinary disorders | MedDRA (27.1) | Non-systematic Assessment | Pollakiuria |
|
| Worsening Hyperlipidemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Worsening of Prostatic Hyperplasia with Urinary Frequency | Reproductive system and breast disorders | MedDRA (27.1) | Non-systematic Assessment | Benign Prostatic Hyperplasia |
|
| Arthralgias | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bronchial Infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Chronic Renal Failure | Renal and urinary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| COVID-19 Infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lower Limb Edema | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Muscle Pain in Arms and Thighs | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment | Myalgia |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pyelonephritis E.coli Urinary Tract Infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Serious Otitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment | Ear Infection |
|
| Unknown Allergic Reaction | Immune system disorders | MedDRA (27.1) | Non-systematic Assessment | Hypersensitivity |
|
| Vomiting | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Creatinine Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Average QTCF Greater than 450ms | Investigations | MedDRA (27.1) | Non-systematic Assessment | Electrocardiogram Qt Prolonged |
|
| Pneumonia | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Conjunctivitis Immunomediated | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Erythema Face and Chest | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lipase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Melanoderma | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Mucositis Oral | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment | Stomatitis |
|
| Seborrheic Keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Trunk Rash | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Watery Eyes | Eye disorders | MedDRA (27.1) | Non-systematic Assessment | Lacrimation |
|
| Chest Pain | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Deterioration of General Condition | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hand Foot Syndrome | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment | Palmar-Plantar Erythrodysaesthesia Syndrome |
|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Platelets Count Decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Skin Rash | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Weight Loss | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bulbar Gastric Ulcer | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Eosinophil Count Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Increased Alkaline Phosphatase | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Increased Basophils | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Increased Lactate Dehydrogenase | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Increased Neutrophils | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Monocytosis | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Non-Pruritic Maculopapular Skin Lesions of the Extremities | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Platelet Count Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Anxiety Worsening | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Electrocardiogram QT Corrected Interval Prolonged | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Neutrophil Count Decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| White Blood Cells Decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Amylase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Upper and Lower Respiratory Tract Infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Body Rash | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Edema in Left Lower Extremity | General disorders | MedDRA (27.1) | Non-systematic Assessment | Oedema Peripheral |
|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Left Femoral Oncologic Pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | Non-systematic Assessment |
| |
| Oral Pain due to Mucositis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment | Stomatitis |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Renal Insufficiency | Renal and urinary disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Duodenal Ulcer | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Feet and Hand Edema | General disorders | MedDRA (27.1) | Non-systematic Assessment | Oedema Peripheral |
|
| Gamma Glutamyltransferase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Influenza A Virus Infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Skin Foot Lesion | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Upper Digestive Bleeding | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment | Upper Gastrointestinal Haemorrhage |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bilateral and Dorsal Chest Pain | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Mucosity (Site Unknown) | General disorders | MedDRA (27.1) | Non-systematic Assessment | Mucosal Inflammation |
|
| Skin Rash on the Chest | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Entercoccus Faecalis Infection | Infections and infestations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Epigastralgia | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment | Abdominal Pain Upper |
|
| Secondary Adrenal Insufficiency | Endocrine disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Lymphocytes Count Decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Malleolus Fracture | Injury, poisoning and procedural complications | MedDRA (27.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thyroid Nodule | Endocrine disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Cranial Theca Pain | Nervous system disorders | MedDRA (27.1) | Non-systematic Assessment | Headache |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Left Shoulder Pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment | Arthralgia |
|
| Right Arm Pain | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Rash (Lateral Thigh) | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Activated Partial Thromboplastin Time Prolonged | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Blurred Vision | Eye disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Edema | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Generalized Muscle Weakness | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Atrial Fibrillation with RVR | Cardiac disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Grade 3 Lymphocyte Count Decreased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Acute Hypoxic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Bowel Perforation | Gastrointestinal disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA (27.1) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Impaired Skin Integrity around Nail Bed | Skin and subcutaneous tissue disorders | MedDRA (27.1) | Non-systematic Assessment |
| |
| Thrombolic Event - Right Ventricle | Vascular disorders | MedDRA (27.1) | Non-systematic Assessment | Embolism |
|
The study was terminated early due to lack of efficacy, therefore the study enrolled a smaller than planned number of participants.
The disclosure agreement outlines that PIs are not to disclose study results without prior discussion with the study Sponsor
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| BerGenBio Clinical Team | BerGenBio ASA | +47 559 61 159 | registry.postings@bergenbio.com |
| Sep 10, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| 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 |
|---|---|
| C548378 | bemcentinib |
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| 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 |
|
| United States |
|
| Italy |
|
| France |
|
| Spain |
|
|
|