OncoMatch/Clinical Trials/NCT06616584
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)
Is NCT06616584 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including Cemiplimab and Ramucirumab for recurrent lung non-small cell carcinoma.
Treatment: Cemiplimab · Dexamethasone · Docetaxel · Ramucirumab — This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Allowed: ALK fusion
Allowed: BRAF sensitizing mutation
Allowed: EGFR sensitizing mutation
Allowed: HER2 (ERBB2) sensitizing mutation
Allowed: KRAS sensitizing mutation
Allowed: MET sensitizing mutation
Allowed: NTRK1 fusion
Allowed: NTRK2 fusion
Allowed: NTRK3 fusion
Allowed: RET fusion
Allowed: ROS1 fusion
Disease stage
Required: Stage IV (AJCC v8)
Stage IV Lung Cancer AJCC v8
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances)
Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below)... Participants must have experienced disease progression (in the opinion of the treating investigator) more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
Must have received: anti-PD-L1 therapy — advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances)
Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances outlined below)... Participants must have experienced disease progression (in the opinion of the treating investigator) more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or anti-PD-L1 therapy
Must have received: platinum-based chemotherapy
Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating investigator) during or after this regimen
Cannot have received: docetaxel (docetaxel)
Participants must not have received prior therapy with docetaxel for this disease
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10^3/uL; Hemoglobin ≥ 9.0 g/dL; Platelets ≥ 100 x 10^3/uL
Kidney function
creatinine ≤ institutional ULN or calculated creatinine clearance ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 x institutional ULN (unless history of Gilbert's disease, then ≤ 5 x ULN); AST and ALT ≤ 3 x institutional ULN (≤ 5 x ULN with liver metastasis)
Absolute neutrophil count ≥ 1.5 x 10^3/uL (within 28 days prior to randomization) Hemoglobin ≥ 9.0 g/dL (within 28 days prior to randomization) Platelets ≥ 100 x 10^3/uL (within 28 days prior to randomization) Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to randomization) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to randomization). Participants with history of liver metastasis must have AST and ALT ≤ 5 x ULN Participants must have a creatinine ≤ the institutional (I)ULN or calculated creatinine clearance ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis · Daphne, Alabama
- Thomas Hospital · Fairhope, Alabama
- Mobile Infirmary Medical Center · Mobile, Alabama
- Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland · Saraland, Alabama
- Katmai Oncology Group · Anchorage, Alaska
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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