OncoMatch/Clinical Trials/NCT06216301
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
Is NCT06216301 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including NovoTTF-200T and Pembrolizumab for metastatic non-small cell lung cancer.
Treatment: NovoTTF-200T · Pembrolizumab · Platinum based chemotherapy — This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: EGFR sensitizing mutation
EGFR sensitizing mutation ... directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Excluded: ALK fusion
ALK translocation ... directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Excluded: ROS1 rearrangement
ROS1 ... directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Excluded: RET rearrangement
RET targetable gene rearrangement ... directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Excluded: MET exon 14 skipping mutation
METex14 skipping mutation ... directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Excluded: NTRK1 fusion
NTRK1 ... gene fusion ... directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Excluded: NTRK2 fusion
NTRK2 ... gene fusion ... directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Excluded: BRAF V600 mutation
BRAF V600 mutations directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease is allowed if completed at least 12 months prior to the development of metastatic disease
Have not received prior systemic treatment for their metastatic NSCLC. Subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the therapy was completed at least 12 months prior to the development of metastatic disease.
Cannot have received: anti-PD-1 therapy
Exception: within 12 months prior to randomization
Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to randomization.
Lab requirements
Blood counts
Adequate hematologic function; INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants)
Kidney function
Adequate end-organ function
Liver function
Adequate end-organ function
Adequate hematologic and end-organ function. For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Central Alabama Research · Birmingham, Alabama
- Western Regional Medical Center, LLC · Goodyear, Arizona
- St. Jude Herritage Medical Group · Fullerton, California
- Hoag Family Cancer Institute - Hoag Memorial Hospital · Newport Beach, California
- Sutter Institute for Medical Research · Sacramento, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06216301 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Are patients with EGFR alterations eligible?
No. EGFR sensitizing mutation is an exclusion criterion.
Are patients with ALK alterations eligible?
No. ALK fusion is an exclusion criterion.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages