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The purpose of this study is to understand if treatment with one chemotherapy medication combined with immune therapy (pembrolizumab) is tolerable and effective for patients with lung cancer and performance status of 2 (PS2), which means you have limitations in carrying out certain activities or spend up to half of your day resting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 1: pembrolizumab and Pemetrexed | Experimental | Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days Pembrolizumab 200 mg and Pemetrexed 500 mg/m2 day 1 of 21 day cycle (for non-squamous only) |
|
| Experimental 2: pembrolizumab and Nab-paclitaxel | Experimental | Treatment includes administration of pembrolizumab and chemotherapy, which are administered every 21 days Pembrolizumab 200 mg and Nab-paclitaxel 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles followed by pembrolizumab alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab 200 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events as a Measure of Safety and Tolerability | Determine the rate of treatment-limiting toxicities in patients with advanced non-small cell lung cancer with ECOG PS 2 who are treated with pembrolizumab and single-agent chemotherapy | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Complete Response or Partial Response | Determine the proportion of patients who achieve a complete or partial response as their best overall response based on RECIST v1.1 criteria will be evaluated. Patients with nonevaluable or unknown response status will be considered nonresponders. | 18 Months |
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Inclusion Criteria:
4A. For patients with stage IIIc disease, patients are ineligible for or refuse standard treatment with platinum-double chemotherapy and radiation.
4B. For patients with stage IV disease, platinum doublet chemotherapy is not appropriate, deemed unsafe by the treating physician, or declined by the patient
4C. Screening lab work must meet the following parameters:
4Ca. Absolute neutrophil count (ANC) ≥1000/mm3
4Cb. Platelet count ≥100,000/mm3
4Cc. CrCl>50 (if pemetrexed is to be offered)
4Cd. AST and ALT ≤ 2.5 x ULN
4D. Patients with small, asymptomatic brain metastases are eligible
4E. Women of childbearing potential must be negative for pregnancy testing (urine or blood) and agree to use effective contraception. Viable contraception should be used after trial screening, before initiation of chemotherapy, and throughout the duration of active treatment in the study.
Non-childbearing potential is defined as (by other than medical reasons): -Amenorrheic >2 years
Amenorrheic for <2 years and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation
Post hysterectomy, oophorectomy or tubal ligation. Otherwise the patient must be willing to use 2 adequate barrier methods throughout the study, starting with the screening visit through 120 days after the last dose of study drug
4F.Participants must read or be read and explained the purposes of the study and sign a statement of informed consent prior to participation. Those who do not read or understand English are eligible and may be consented according to institutional regulations.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Baumgart | Contact | 585-275-4401 | Megan_Baumgart@URMC.Rochester.edu |
| Name | Affiliation | Role |
|---|---|---|
| Megan Baumgart | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Not yet recruiting | Rochester | New York | 14642 | United States |
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| Pemetrexed (Chemotherapy) | Other | 500 mg/m2 day 1 of 21 day cycle (for non-squamous only) |
|
| Nab-paclitaxel (Chemotherapy) | Other | 100 mg/m2 days 1,8 of 21 day cycle x 4 cycles |
|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
| 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 |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D004358 | Drug Therapy |
| C520255 | 130-nm albumin-bound paclitaxel |
| 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 |
| D013812 | Therapeutics |
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