Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-… (NCT07524257) | Clinical Trial Compass
WithdrawnPhase 3
Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC
Stopped: Sponsor decision
0Started 2026-05-29
Plain-language summary
This is a randomized, open-label, phase 3 study evaluating nogapendekin alfa inbakicept (NAI) plus chemoimmunotherapy containing pembrolizumab and platinum-based chemotherapy versus chemoimmunotherapy alone as first-line treatment in patients with stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations. Primary endpoint is progression-free survival by RECIST v1.1 based on blinded independent central review.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years.
* Pathologically confirmed stage IV NSCLC (squamous or nonsquamous).
* No prior systemic chemotherapy for advanced/metastatic NSCLC.
* Tumor lacks an actionable genomic alteration with approved first-line targeted therapy (EGFR, ALK etc.; AGA status from local or central testing; ctDNA acceptable if tissue unavailable).
* PD L1 result available before randomization: TPS ≥1%, \<1%, or unknown.
* ECOG performance status 0-1.
* At least one measurable lesion per RECIST v1.1.
* Able to attend visits and follow-up.
* Contraception requirements for women of childbearing potential and nonsterile males, with 7 month post-last-dose window.
Exclusion Criteria:
* Body weight \<40 kg.
* Serious uncontrolled concomitant disease.
* Certain prior malignancies (exceptions: adequately treated or nonmetastatic, as per protocol).
* Active autoimmune disease requiring systemic treatment (exceptions: autoimmune thyroiditis, etc.).
* Prior organ transplant requiring immunosuppression.
* Prior pneumonitis/interstitial lung disease requiring active systemic treatment.
* Prior systemic chemotherapy or immunotherapy within 3 years.
* Requirement for other anticancer therapy while on study (palliative RT allowed).
* Known CNS metastases, carcinomatous meningitis, and/or spinal cord compression (with specified exceptions for treated or asymptomatic brain mets).
* HIV infection or active/uncontrolled HBV/HCV not meeting the protocol's controlled criteria.
* Active …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-Free Survival (PFS) by BICR (RECIST v1.1)
Timeframe: Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; final PFS analysis with follow-up through 156 weeks (3 years) from first dose.