S2302 - Comparing two treatments for advanced lung cancer: one without chemotherapy (using a combination of drugs called ramucirumab and pembrolizumab), and the other following the usual care after immunotherapy
Enrolling By Invitation
All
Phase
3
1 Location
Brief description of study
This study compares the impact of using a combination of drugs, ramucirumab and pembrolizumab, versus standard chemotherapy for treating advanced non-small cell lung cancer that is stage IV or recurrent. Ramucirumab blocks new blood vessel growth that tumors need, while pembrolizumab boosts the immune system to fight cancer. The trial aims to determine if the combination is more effective than traditional chemotherapy in treating stage IV or recurrent non-small cell lung cancer.
Detailed description of study
This study aims to compare the standard treatment to a new approach using the drugs ramucirumab and pembrolizumab. The goal is determine if this drug combination can extend patients' lives. The study is designed to establish whether the drug combination is better, the same, or worse than the usual chemotherapy treatment.
This study is Enrolling by Invitation at Lancaster General Hospital - ABBCI.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
In clinic, in person
-
Gender: All
Inclusion Criteria:
- Participants must have confirmed non-small cell lung cancer (NSCLC), which is stage IV or recurrent
- Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy
- Participants must have experienced disease progression (in the opinion of the treating physician) more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 therapy.
- Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable, partial response or complete response (in the opinion of the treating physician)
- Participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy as their only line of anti-PD-1 or anti-PD-L1 therapy must have experienced disease progression within (=<) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or PD-L1 therapy
- Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of treating physician) during or after this regimen
- Participants with a known sensitizing mutation for which a Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists, must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met.
- Participants must be >= 18 years old
- Participants must be able to safely receive the investigational drug combination and the investigator's choice of standard of care regimens per the current FDA approved package insert(s), treating investigator's discretion, and institutional guidelines
- Participants must have Zubrod performance status of 0-2
Exclusion Criteria:
- Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for stage IV or recurrent disease
- Participants must not be receiving or planning to receive another investigational therapy during study participation
Updated on
04 Apr 2024.
Study ID: S2302
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