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Report for Clinical Trial NCT03971474

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

This phase II Lung-MAP non-Match treatment trial studies how well ramucirumab and pembrolizumab work versus standard of care in treating patients with non-small cell lung cancer that is stage IV or has come back. Immunotherapy with monoclonal antibodies, such as ramucirumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in standard of care chemotherapy for non-small cell lung cancer, such as docetaxel, gemcitabine hydrochloride, and pemetrexed, 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. Giving ramucirumab and pembrolizumab together may work better in treating patients with non-small lung cancer compared to standard of care.

NCT03971474 Recurrent Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

7 Interventions

Name: Docetaxel

Description: Given IV
Type: Drug
Group Labels: 1

Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)

Name: Gemcitabine

Description: Given IV
Type: Drug
Group Labels: 1

Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)

Name: Gemcitabine Hydrochloride

Description: Given IV
Type: Drug
Group Labels: 1

Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)

Name: Pembrolizumab

Description: Given IV
Type: Biological
Group Labels: 2

Arm B (ramucirumab, Arm B (ramucirumab, pembrolizumab)

Name: Pemetrexed

Description: Given IV
Type: Drug
Group Labels: 1

Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)

Name: Pemetrexed Disodium

Description: Given IV
Type: Drug
Group Labels: 1

Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed)

Name: Ramucirumab

Description: Given IV
Type: Biological
Group Labels: 2

Arm A (docetaxel, gemcitabine, ramucirumab, pemetrexed) Arm B (ramucirumab, pembrolizumab)


Primary Outcomes

Description: Will be compared between patients previously treated with platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer randomized to ramucirumab and MK-3475 (pembrolizumab) versus standard of care (SoC). Will be estimated using the method of Kaplan-Meier.

Measure: Overall survival (OS)

Time: Up to 3 years

Secondary Outcomes

Description: Will be estimated using the method of Kaplan-Meier. Median and landmark time-point estimates will be based on the Kaplan-Meier estimates. The average hazard ratio (HR) will be estimated using a Cox proportional hazards model. An assessment of the proportional hazards assumption will be performed and an assessment of the time-dependent HR will be done.

Measure: Investigator assessed-progression-free survival (IA-PFS)

Time: From date of sub-study registration to date of first documentation of progression assessed by central review or symptomatic deterioration, or death due to any cause, assessed up to 3 years

Description: Will be estimated using the method of Kaplan-Meier. Median and landmark time-point estimates will be based on the Kaplan-Meier estimates. The average HR will be estimated using a Cox proportional hazards model. An assessment of the proportional hazards assumption will be performed and an assessment of the time-dependent HR will be done.

Measure: Duration of response (DOR)

Time: From date of first documentation of response (CR or PR), or death due to any cause among patients who achieve a response (CR or PR), assessed up to 3 years

Description: Binary proportions will be summarized with associated confidence intervals. Will be compared with toxicities using a chi-squared test at the 1-sided 0.05 level.

Measure: Response rates (RR)

Time: Up to 3 years

Description: Will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Binary proportions will be summarized with associated confidence intervals. Will be compared with RR using a chi-squared test at the 1-sided 0.05 level.

Measure: Incidence of adverse events

Time: Up to 3 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 3 SNPs

SNPs


1 S1800A

Will be compared with RR using a chi-squared test at the 1-sided 0.05 level.. Inclusion Criteria: - Patients must have been assigned to S1800A by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). --- S1800A ---

However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures during the study and 4 months after study completion - Patients must agree to have blood specimens submitted for circulating tumor DNA (ctDNA) - Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - Patients with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator) - Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines Inclusion Criteria: - Patients must have been assigned to S1800A by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). --- S1800A ---


2 T790M

Patients who were screened under S1400 (legacy screening/pre-screening study) must have had prior PD-L1 testing by the Dako 22C3 PharmDx immunohistochemistry (IHC) assay, and must have results available for stratification purposes - Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy - Patients must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). --- T790M ---


3 V600E

Patients who were screened under S1400 (legacy screening/pre-screening study) must have had prior PD-L1 testing by the Dako 22C3 PharmDx immunohistochemistry (IHC) assay, and must have results available for stratification purposes - Patients must not have EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, and BRAF V600E mutation unless they have progressed following all standard of care targeted therapy - Patients must not have an active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). --- T790M --- --- V600E ---



HPO Nodes


HPO: