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New treatment option for Metastatic Non-small Cell Lung Cancer
Official title LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
ClinicalTrials.gov ID: NCT06216301
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, being studied as a potential treatment for metastatic non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥22 years of age in the USA ≥18 years of age outside of the USA.
- Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer [AJCC] criteria) non-squamous...
- Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1.
- Have not received prior systemic treatment for their metastatic NSCLC. people who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy...
- ECOG Performance Status (PS) of 0-1.
You likely can't join if
- All individuals meeting any of the following exclusion criteria will be excluded from study participation:
- Mixed small cell and NSCLC histology.
- EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET targetable gene rearrangement, and/or METex14 skipping mutation, and/or...
- Has received systemic therapy for metastatic disease.
- Had major surgery \<3 weeks prior to randomization
- Received radiation therapy to the lung that is \> 30 Gy within 6 months of randomization.
See the full eligibility criteria
- ≥22 years of age in the USA ≥18 years of age outside of the USA.
- Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer [AJCC] criteria) non-squamous or squamous NSCLC.
- Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1.
- Have not received prior systemic treatment for their metastatic NSCLC. people who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the...
- ECOG Performance Status (PS) of 0-1.
- Adequate hematologic and end-organ function o For people 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...
- A female participant is eligible to participate if she is not pregnant, not breastfeeding
- If male subject with a female partner(s) of child-bearing potential, must agree to use an effective contraception
- All people must sign written informed consent.
- All individuals meeting any of the following exclusion criteria will be excluded from study participation:
- Mixed small cell and NSCLC histology.
- EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET targetable gene rearrangement, and/or METex14 skipping mutation, and/or NTRK1/2 gene fusion and/or BRAF V600 mutations directed therapy is...
- Has received systemic therapy for metastatic disease.
- Had major surgery \<3 weeks prior to randomization
- Received radiation therapy to the lung that is \> 30 Gy within 6 months of randomization.
- Has received prior radiotherapy within 2 weeks of randomization. people must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is...
- Is expected to require any other form of antineoplastic therapy while on study.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Note: people with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not...
- Has symptomatic Central Nervous System (CNS) metastases and/or carcinomatous meningitis. people with asymptomatic CNS metastases or with previously treated brain metastases may participate provided they were treated...
- Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior...
- 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.
- Participation in another clinical study with an investigational agent or device during the 4 weeks prior to randomization.
- Concurrent treatment with other experimental treatments for NSCLC while in the study.
- Has a known sensitivity to any component of the planned systemic therapies (pembrolizumab, cisplatin/carboplatin, pemetrexed/paclitaxel/nab-paclitaxel) .
- Pregnant or breastfeeding
- Admitted to an institution by administrative or court order.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Goodyear, Arizona, United States
- Fullerton, California, United States
- Newport Beach, California, United States
- Sacramento, California, United States
- Ocala, Florida, United States
- Tampa, Florida, United States
- Barrington, Illinois, United States
- Elmhurst, Illinois, United States
- Naperville, Illinois, United States
- Zion, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Westwood, Kansas, United States
- Annapolis, Missouri, United States
- Kansas City, Missouri, United States
- Lee's Summit, Missouri, United States
- Overland, Missouri, United States
- New Hyde Park, New York, United States
- New York, New York, United States
+ 74 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Goodyear, Arizona, United States; Fullerton, California, United States; Newport Beach, California, United States; Sacramento, California, United States; Ocala, Florida, United States and 88 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.