Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) (NCT05096663)

🧪 Interventions in This Study

• Cobalamin (DIETARY_SUPPLEMENT)
• Dexamethasone (DRUG)
• Docetaxel (DRUG)
• Folic Acid (DIETARY_SUPPLEMENT)
• Gemcitabine (DRUG)
• Nogapendekin Alfa (DRUG)
• Pembrolizumab (BIOLOGICAL)
• Pemetrexed (DRUG)
• Ramucirumab (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants must have been assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol
2. Participants must have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to randomization. Non-measurable disease must be assessed within 42 days prior to randomization. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
3. Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
4. Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization
5. Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (=\< 10 mg daily prednisone or equivalent) prior to sub-study randomization
6. Participants must have progressed (in the opinion of the treating investigator) following the most recent line of therapy for non-small cell lung cancer (NSCLC)
7. Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s)
8. Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent, or stage III in certain circumstances outlined below) given alone or in combination with platinum-based chemotherapy. Participants must have experienced disease progression during or after this regimen
9. Continuing the same agent(s) after progression counts as a single line of therapy. However, a change or addition in agent(s) after progression (e.g. the addition of chemotherapy to anti-PD-1 monotherapy after progression) counts as a subsequent line of therapy and would exclude the participant
10. For participants who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy:
11. If they experienced disease progression less than (\<) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this counts as the single line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
12. If they experienced disease progression more than or equal to (\>=) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this is not considered a line of anti-PD-1 or anti-PD-L1 therapy for advanced disease

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (350 Sites)

Showing the first 25 of 350 sites.

• Veterans Administration Medical Center - Birmingham — Birmingham, Alabama
• CTCA at Western Regional Medical Center — Goodyear, Arizona
• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• Kaiser Permanente-Anaheim — Anaheim, California
• PCR Oncology — Arroyo Grande, California
• Sutter Auburn Faith Hospital — Auburn, California
• Kaiser Permanente-Baldwin Park — Baldwin Park, California
• Kaiser Permanente-Bellflower — Bellflower, California
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
• Tower Cancer Research Foundation — Beverly Hills, California
• Kaiser Permanente-Fontana — Fontana, California
• Palo Alto Medical Foundation-Fremont — Fremont, California
• Kaiser Permanente - Harbor City — Harbor City, California
• Kaiser Permanente-Irvine — Irvine, California
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California
• Kaiser Permanente West Los Angeles — Los Angeles, California
• Cedars Sinai Medical Center — Los Angeles, California
• Memorial Medical Center — Modesto, California
• Kaiser Permanente-Oakland — Oakland, California
• Kaiser Permanente-Ontario — Ontario, California
• Palo Alto Medical Foundation Health Care — Palo Alto, California
• Kaiser Permanente - Panorama City — Panorama City, California
• Eisenhower Medical Center — Rancho Mirage, California
• Kaiser Permanente-Riverside — Riverside, California
• Kaiser Permanente-Roseville — Roseville, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Advanced Lung Non-Small Cell Carcinoma

• Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer — Duarte, California
• Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change — Anchorage, Alaska
• Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy — Atlanta, Georgia
• Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer — Birmingham, Alabama
• GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer — Buffalo, New York
• MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer — Atlanta, Georgia

Explore by condition: All Advanced Lung Non-Small Cell Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.