Actively Recruiting
A Randomized Phase IIIII Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer Lung-MAP Non-Matched Sub-Study
Led by SWOG Cancer Research Network · Updated on 2026-05-05
378
Participants Needed
386
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
SWOG Cancer Research Network
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating treatments for patients with stage IV or recurring non-small cell lung cancer who have previously received platinum chemotherapy and immunotherapy. This phase IIIII trial compares the effects of adding cemiplimab, an immune system-stimulating monoclonal antibody, to the usual combination of docetaxel and ramucirumab. The goal is to see if adding cemiplimab helps the immune system better attack tumor cells and improves survival outcomes. Participants are randomly assigned to one of two groups. One group receives docetaxel and ramucirumab along with dexamethasone, while the other group receives these same treatments plus cemiplimab. Treatments are given in cycles every 21 days, with infusions lasting from 30 minutes to an hour depending on the drug. Patients undergo regular blood sample collections and imaging scans such as CT or MRI throughout the study. During the trial, participants are monitored for overall survival, disease progression, tumor response, and side effects. After completing treatment, follow-up visits occur every 3 to 6 months for up to 3 years. Blood tests and imaging help assess treatment effects and safety. Researchers also collect and store blood and tissue samples to support future studies.
CONDITIONS
Brief Title
Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be assigned to S1800E by the SWOG Statistics and Data Management Center as part of the LUNGMAP protocol
- Participants must have measurable or non-measurable disease documented by CT or MRI within specified timeframes
- Participants must have a brain CT or MRI scan within 42 days before randomization
- Must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease or specific criteria for earlier stages
- Must have experienced disease progression more than 84 days after starting the most recent anti-PD-1 or anti-PD-L1 therapy
- Must have had stable disease, partial response, or complete response to prior anti-PD-1 or anti-PD-L1 therapy for advanced disease
- Must have received platinum-based chemotherapy and experienced disease progression during or after this regimen
- Participants with known sensitizing molecular alterations must have received at least one approved targeted therapy
- Must have recovered to grade 1 or less from side effects of the most recent anti-cancer treatment
- Must not have received prior docetaxel therapy for this disease
- Must not have had recent palliative radiation therapy within specified timeframes
- Must not be receiving other concurrent chemotherapy, immunotherapy, or biologic therapy
- Must not have had major surgery or venous access device placement within specified timeframes
- Must meet specified laboratory values for blood counts, liver and kidney function within 28 days before randomization
- Must have ECOG performance status of 0-1 documented within 28 days
- Must have completed medical history and physical exam within 28 days
- Participants with hepatitis B, C, or HIV must meet specific viral load and treatment criteria
- Must not have prior or concurrent malignancy interfering with safety or efficacy
- Must not have active autoimmune disease requiring systemic treatment within 730 days
- Must not have history of primary immunodeficiency or organ transplant requiring immunosuppressives
- Must not have received live vaccines within 28 days before randomization
- Must not have active tuberculosis or pneumonitis/interstitial lung disease
- Must not have recent serious wound, ulcer, bone fracture, or gastrointestinal complications
- Must not have serious cardiac disease or recent arterial thromboembolic events
- Must not have gross hemoptysis or major blood vessel invasion by cancer
- Must not be pregnant or breastfeeding and must agree to use effective contraception if of reproductive potential
- Must agree to blood specimen collection for circulating tumor DNA and specimen banking
- Must provide informed consent according to guidelines
You will not qualify if you...
- Prior therapy with docetaxel for this disease
- Palliative radiation therapy within 14 days (or bone radiation within 7 days) prior to randomization
- Major surgery within 28 days or venous access device placement within 7 days prior to randomization
- Postoperative bleeding or wound complications within 2 months prior to randomization
- Active autoimmune disease requiring systemic treatment within 730 days prior to randomization
- History of primary immunodeficiency
- History of organ transplant requiring immunosuppressive drugs
- Receipt of live or live attenuated vaccines within 28 days prior to randomization
- Clinical signs or symptoms of active tuberculosis infection
- History of pneumonitis requiring steroids or current pneumonitis/interstitial lung disease
- Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
- History of gastrointestinal perforation or fistula within 6 months prior to randomization
- Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization
- Grade III/IV cardiac disease, unstable angina, recent myocardial infarction, or serious uncontrolled arrhythmia
- Arterial thromboembolic events within 6 months prior to randomization
- Gross hemoptysis or major blood vessel invasion by cancer within 2 months prior to randomization
- Venous thrombosis within 3 months prior to randomization unless on stable anticoagulants
- Cirrhosis at Child-Pugh B or worse with complications, or any degree of cirrhosis
- Pregnancy or breastfeeding
- Not agreeing to use effective contraception if of reproductive potential
Research Team
J
Jennifer Beeler
S
SWOG Network Operations Center
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