NSCLC (Advanced Non-small Cell Lung Cancer)Phase 3NCT07524257
Phase 3 Study of Nogapendekin Alfa Inbakicept Plus Standard of Care vs Standard of Care in First-Line Advanced or Metastatic NSCLC
A Phase 3 study testing Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab and Cisplatin or Carboplatin in people with NSCLC (Advanced Non-small Cell Lung Cancer) and Metastatic NSCLC, run by ImmunityBio, Inc..
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer), Metastatic NSCLC
- What is being tested?
- Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab and Cisplatin or Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 29 May 2026to 30 Dec 2029
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 infection requiring IV therapy.
- Inadequate organ function:
- ANC <1,500/mm³; platelets <100,000/mm³; Hgb <9 g/dL.
- Total bilirubin >1.5×ULN (with defined Gilbert's exception).
- AST/ALT >1.5×ULN (or >5×ULN with liver mets).
- ALP >2.5×ULN (or >5×ULN with bone mets).
- Creatinine clearance <40 mL/min (Cockcroft-Gault).
- Significant cardiovascular disease (uncontrolled HTN, recent MI, stroke, CHF ≥NYHA II, serious arrhythmia).
- Known hypersensitivity to study drugs.
- Concomitant medications known to interact adversely with study drugs.
- Participation in another investigational drug/device study (except hormone-lowering therapy).
- Pregnancy or breastfeeding.
- Confinement by court order/authority.
- Any condition or noncompliance that, in Investigator judgment, precludes participation.
About this study
Official title: Phase 3, Randomized, Open-Label Study of Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
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.
Read the detailed description
This is a phase 3, randomized, open-label, parallel-group clinical trial evaluating nogapendekin alfa inbakicept (NAI; an IL-15 receptor agonist) in combination with standard first-line chemoimmunotherapy versus standard chemoimmunotherapy alone in participants with stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations that have approved targeted therapies. Approximately 494 participants will be randomized 1:1 to receive either NAI plus pembrolizumab and platinum-based chemotherapy (experimental arm) or pembrolizumab and platinum-based chemotherapy alone (control arm), with the possibility of increasing the sample size up to 960 participants based on an interim progression-free survival (PFS) analysis.
In the experimental arm, participants receive induction therapy for up to 4 cycles (21-day cycles) with pembrolizumab 200 mg IV plus cisplatin 75 mg/m² IV or carboplatin AUC 5-6 IV, and a histology-specific third agent (nab-paclitaxel 100 mg/m² IV on Days 1, 8, and 15 for squamous NSCLC, or pemetrexed 500 mg/m² IV on Day 1 for nonsquamous NSCLC), in combination with NAI 1.2 mg subcutaneously (SC) on Day 1 of each cycle (participants ≥100 kg receive NAI 15 μg/kg SC). In the maintenance phase (cycles ≥5), participants in the experimental arm continue pembrolizumab 200 mg IV every 3 weeks with NAI 1.2 mg SC every 3 weeks, with pemetrexed 500 mg/m² IV continued in nonsquamous NSCLC. In the control arm, participants receive the same pembrolizumab plus platinum backbone, with squamous participants receiving either nab-paclitaxel, paclitaxel, or docetaxel per regional product labeling, and nonsquamous participants receiving pemetrexed, followed by maintenance pembrolizumab with or without pemetrexed according to histology. All study treatment is administered for up to 35 cycles (approximately 2 years), or until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Tumor assessments (CT or MRI) are performed at screening, at week 6 and week 12 following Cycle 1 Day 1, and every 9 weeks (±7 days) thereafter, and tumor response is evaluated per RECIST v1.1 and immune RECIST (iRECIST). The primary endpoint is PFS per RECIST v1.1 as assessed by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS) and objective response rate (ORR) per RECIST v1.1 by BICR. Other secondary endpoints include PFS, ORR, duration of response (DOR), and disease control rate (DCR) by iRECIST (BICR) and by Investigator assessment, change in absolute lymphocyte count (ALC) over time, duration of immune competence (ALC ≥1,000 cells/µL), disease-specific survival (DSS), and safety (treatment-emergent adverse events, serious adverse events, laboratory parameters, vital signs, and ECGs). The study also includes exploratory analyses of whole slide images and blood/tissue-based molecular profiling to explore correlations with clinical outcomes.
- Being tested
- Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab, Cisplatin or Carboplatin, Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous), Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous)
- Keywords
- non-small cell lung cancer, NSCLC, nogapendekin alfa inbakicept, NAI, ANKTIVA, IL-15 agonist, chemoimmunotherapy, pembrolizumab, platinum chemotherapy, pemetrexed, paclitaxel, nab-paclitaxel, progression-free survival, immunotherapy, molecular profiling
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: Nogapendekin alfa inbakicept (NAI)Drug
1.2 mg SC q3 weeks (15 μg/kg SC if ≥100 kg), up to 35 cycles.
PembrolizumabDrug
200 mg IV q3 weeks.
Cisplatin or CarboplatinDrug
Cisplatin 75 mg/m² IV q3w OR carboplatin AUC 5-6 IV q3w (per label).
Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous)Drug
Squamous: nab-paclitaxel 100 mg/m² IV on Days 1, 8, 15 of cycles 1-4. Nonsquamous: pemetrexed 500 mg/m² IV Day 1 q3w, up to 35 cycles.
Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous)Drug
Nab-paclitaxel 100 mg/m² IV D1, 8, 15 or paclitaxel 175 mg/m² IV D1 or docetaxel 75 mg/m² IV D1 (per RHA label/local guidelines) for cycles 1-4 in squamous participants.
Pemetrexed (nonsquamous)Drug
First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: NAI + Pembrolizumab + Chemotherapy | Experimental | First-line stage IV NSCLC; induction (≤4 cycles) with pembrolizumab + platinum + nab-paclitaxel (squamous) or pemetrexed (nonsquamous) plus NAI, followed by maintenance pembrolizumab ± pemetrexed plus NAI. Receives: Drug: Drug: Nogapendekin alfa inbakicept (NAI); Drug: Pembrolizumab; Drug: Cisplatin or Carboplatin; Drug: Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous) |
| Active Comparator: Pembrolizumab + Chemotherapy | Active comparator | First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific. Receives: Drug: Pembrolizumab; Drug: Cisplatin or Carboplatin; Drug: Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous); Drug: Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous); Drug: Pemetrexed (nonsquamous) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) by BICR (RECIST v1.1)
PFS is defined as the time from randomization to the first documentation of disease progression per RECIST v1.1 by blinded independent central review (BICR) or death from any cause, whichever occurs first.
Measured: 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.
Secondary outcomes (9)
Overall survival (OS)
Time from randomization to death from any cause.
Measured: From first dose until death, with survival follow-up through 156 weeks (3 years) from first dose.
Objective Response Rate (ORR) by BICR (RECIST v1.1)
ORR is the proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 by BICR.
Measured: Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; ORR assessed up to 156 weeks (3 years) from first dose.
Change in Absolute Lymphocyte Count (ALC) Over Time
Change from baseline in absolute lymphocyte count over time by treatment group.
Measured: At scheduled study visits from first dose through 156 weeks (3 years) from first dose or end of treatment, whichever occurs first.
Duration of Immune Competence (ALC ≥1,000 cells/µL)
Duration of immune competence, defined as the time during treatment that ALC remains ≥1,000 cells/µL.
Measured: From first dose until treatment discontinuation; duration of immune competence assessed up to 156 weeks (3 years) from first dose.
Duration of Response (DOR) by BICR (RECIST v1.1)
For participants with a confirmed CR or PR per RECIST v1.1 by BICR, DOR is defined as the time from the date of first documented response (CR or PR) to the date of disease progression per RECIST v1.1 by BICR or death from any cause, whichever occurs first.
Measured: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DOR assessed up to 156 weeks (3 years) from first dose.
Disease Control Rate (DCR) by BICR (RECIST v1.1)
DCR is the proportion of participants with CR, PR, or stable disease (SD) lasting at least 2 months per RECIST v1.1 as assessed by BICR.
Measured: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DCR assessed up to 156 weeks (3 years) from first dose.
PFS, ORR, DOR, and DCR by BICR Using iRECIST
PFS, ORR, DOR, and DCR assessed per immune RECIST (iRECIST) as determined by BICR, using the same definitions as for RECIST v1.1 but applying iRECIST rules.
Measured: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose.
PFS, ORR, DOR, and DCR by Investigator Assessment (RECIST v1.1 and iRECIST)
PFS, ORR, DOR, and DCR per RECIST v1.1 and iRECIST as assessed by site Investigators, using the same definitions as for BICR.
Measured: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose.
Disease-specific survival (DSS)
DSS is defined as the time from randomization to death due to NSCLC. Deaths from other causes are censored at the date of death.
Measured: From first dose until death due to NSCLC, with follow-up through 156 weeks (3 years) from first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start29 May 2026 (estimated)
- Primary completion15 May 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to two parallel treatment arms (NAI + pembrolizumab + platinum-based chemotherapy vs pembrolizumab + platinum-based chemotherapy alone). Randomization is stratified by tumor histology (squamous vs nonsquamous NSCLC) and PD-L1 tumor proportion score (TPS ≥1% vs \<1%, with "unknown" PD-L1 classified as \<1%). Each participant remains on the assigned arm throughout the study; there is no planned crossover.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524257
- Sponsor's protocol ID
- ResQ1010-NSCLC
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data to be shared include: unique study ID; demographics and baseline characteristics (age, sex, ECOG, histology, PD-L1, AGA status); treatment assignment and exposure (dates offset, doses, modifications); efficacy outcomes and dates (tumor measurements, RECIST/iRECIST responses, PFS, OS, DOR, DCR); safety data (AEs/SAEs with MedDRA codes, CTCAE grade, relatedness); lab results, vitals/ECGs, concomitant meds; processed biomarker datasets and derived pathology/image features. Raw direct identifiers and physical specimens require separate agreements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Randomized, Open-Label Study of Nogapendekin Alfa Inbakicept in Combination With Standard of Care Versus Standard of Care as First-Line Treatment for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07524257
- Acronym / sponsor ID
- ResQ1010-NSCLC
- Keywords
- non-small cell lung cancer, NSCLC, nogapendekin alfa inbakicept, NAI, ANKTIVA, IL-15 agonist, chemoimmunotherapy, pembrolizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (estimated)
- Primary completion
- 15 May 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase 3, randomized, open-label, parallel-group clinical trial evaluating nogapendekin alfa inbakicept (NAI; an IL-15 receptor agonist) in combination with standard first-line chemoimmunotherapy versus standard chemoimmunotherapy alone in participants with stage IV squamous or nonsquamous non-small cell lung cancer (NSCLC) without actionable genomic alterations that have approved targeted therapies. Approximately 494 participants will be randomized 1:1 to receive either NAI plus pembrolizumab and platinum-based chemotherapy (experimental arm) or pembrolizumab and platinum-based chemotherapy alone (control arm), with the possibility of increasing the sample size up to 960 participants based on an interim progression-free survival (PFS) analysis.
In the experimental arm, participants receive induction therapy for up to 4 cycles (21-day cycles) with pembrolizumab 200 mg IV plus cisplatin 75 mg/m² IV or carboplatin AUC 5-6 IV, and a histology-specific third agent (nab-paclitaxel 100 mg/m² IV on Days 1, 8, and 15 for squamous NSCLC, or pemetrexed 500 mg/m² IV on Day 1 for nonsquamous NSCLC), in combination with NAI 1.2 mg subcutaneously (SC) on Day 1 of each cycle (participants ≥100 kg receive NAI 15 μg/kg SC). In the maintenance phase (cycles ≥5), participants in the experimental arm continue pembrolizumab 200 mg IV every 3 weeks with NAI 1.2 mg SC every 3 weeks, with pemetrexed 500 mg/m² IV continued in nonsquamous NSCLC. In the control arm, participants receive the same pembrolizumab plus platinum backbone, with squamous participants receiving either nab-paclitaxel, paclitaxel, or docetaxel per regional product labeling, and nonsquamous participants receiving pemetrexed, followed by maintenance pembrolizumab with or without pemetrexed according to histology. All study treatment is administered for up to 35 cycles (approximately 2 years), or until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Tumor assessments (CT or MRI) are performed at screening, at week 6 and week 12 following Cycle 1 Day 1, and every 9 weeks (±7 days) thereafter, and tumor response is evaluated per RECIST v1.1 and immune RECIST (iRECIST). The primary endpoint is PFS per RECIST v1.1 as assessed by blinded independent central review (BICR). Key secondary endpoints include overall survival (OS) and objective response rate (ORR) per RECIST v1.1 by BICR. Other secondary endpoints include PFS, ORR, duration of response (DOR), and disease control rate (DCR) by iRECIST (BICR) and by Investigator assessment, change in absolute lymphocyte count (ALC) over time, duration of immune competence (ALC ≥1,000 cells/µL), disease-specific survival (DSS), and safety (treatment-emergent adverse events, serious adverse events, laboratory parameters, vital signs, and ECGs). The study also includes exploratory analyses of whole slide images and blood/tissue-based molecular profiling to explore correlations with clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized 1:1 to two parallel treatment arms (NAI + pembrolizumab + platinum-based chemotherapy vs pembrolizumab + platinum-based chemotherapy alone). Randomization is stratified by tumor histology (squamous vs nonsquamous NSCLC) and PD-L1 tumor proportion score (TPS ≥1% vs <1%, with "unknown" PD-L1 classified as <1%). Each participant remains on the assigned arm throughout the study; there is no planned crossover.
| Arm | Type | Receives |
|---|---|---|
| Experimental: NAI + Pembrolizumab + Chemotherapy | Experimental | Drug: Drug: Nogapendekin alfa inbakicept (NAI), Drug: Pembrolizumab, Drug: Cisplatin or Carboplatin, Drug: Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous)First-line stage IV NSCLC; induction (≤4 cycles) with pembrolizumab + platinum + nab-paclitaxel (squamous) or pemetrexed (nonsquamous) plus NAI, followed by maintenance pembrolizumab ± pemetrexed plus NAI. |
| Active Comparator: Pembrolizumab + Chemotherapy | Active comparator | Drug: Pembrolizumab, Drug: Cisplatin or Carboplatin, Drug: Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous), Drug: Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous), Drug: Pemetrexed (nonsquamous)First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: Nogapendekin alfa inbakicept (NAI)1.2 mg SC q3 weeks (15 μg/kg SC if ≥100 kg), up to 35 cycles. | Drug | Experimental: NAI + Pembrolizumab + Chemotherapy |
| Pembrolizumab200 mg IV q3 weeks. | Drug | Active Comparator: Pembrolizumab + Chemotherapy, Experimental: NAI + Pembrolizumab + Chemotherapy |
| Cisplatin or CarboplatinCisplatin 75 mg/m² IV q3w OR carboplatin AUC 5-6 IV q3w (per label). | Drug | Active Comparator: Pembrolizumab + Chemotherapy, Experimental: NAI + Pembrolizumab + Chemotherapy |
| Nab-paclitaxel (squamous) OR Pemetrexed (nonsquamous)Squamous: nab-paclitaxel 100 mg/m² IV on Days 1, 8, 15 of cycles 1-4. Nonsquamous: pemetrexed 500 mg/m² IV Day 1 q3w, up to 35 cycles. | Drug | Active Comparator: Pembrolizumab + Chemotherapy, Experimental: NAI + Pembrolizumab + Chemotherapy |
| Nab-paclitaxel OR Paclitaxel OR Docetaxel (squamous)Nab-paclitaxel 100 mg/m² IV D1, 8, 15 or paclitaxel 175 mg/m² IV D1 or docetaxel 75 mg/m² IV D1 (per RHA label/local guidelines) for cycles 1-4 in squamous participants. | Drug | Active Comparator: Pembrolizumab + Chemotherapy |
| Pemetrexed (nonsquamous)First-line standard-of-care chemoimmunotherapy per pembrolizumab + platinum doublet regimens, histology-specific. | Drug | Active Comparator: Pembrolizumab + Chemotherapy |
Primary outcome
Progression-Free Survival (PFS) by BICR (RECIST v1.1)
Time frame: 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.
PFS is defined as the time from randomization to the first documentation of disease progression per RECIST v1.1 by blinded independent central review (BICR) or death from any cause, whichever occurs first.
9 secondary outcomes
Overall survival (OS)
Time frame: From first dose until death, with survival follow-up through 156 weeks (3 years) from first dose.
Objective Response Rate (ORR) by BICR (RECIST v1.1)
Time frame: Imaging every 9 weeks (±7 days) from first dose (after initial assessments at week 6 and week 12) until treatment discontinuation; ORR assessed up to 156 weeks (3 years) from first dose.
Change in Absolute Lymphocyte Count (ALC) Over Time
Time frame: At scheduled study visits from first dose through 156 weeks (3 years) from first dose or end of treatment, whichever occurs first.
Duration of Immune Competence (ALC ≥1,000 cells/µL)
Time frame: From first dose until treatment discontinuation; duration of immune competence assessed up to 156 weeks (3 years) from first dose.
Duration of Response (DOR) by BICR (RECIST v1.1)
Time frame: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DOR assessed up to 156 weeks (3 years) from first dose.
Disease Control Rate (DCR) by BICR (RECIST v1.1)
Time frame: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; DCR assessed up to 156 weeks (3 years) from first dose.
PFS, ORR, DOR, and DCR by BICR Using iRECIST
Time frame: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose.
PFS, ORR, DOR, and DCR by Investigator Assessment (RECIST v1.1 and iRECIST)
Time frame: Tumor imaging at week 6 and week 12 following Cycle 1 Day 1, then every 9 weeks (±7 days) from first dose until treatment discontinuation; each endpoint assessed up to 156 weeks (3 years) from first dose.
Disease-specific survival (DSS)
Time frame: From first dose until death due to NSCLC, with follow-up through 156 weeks (3 years) from first dose.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level data to be shared include: unique study ID; demographics and baseline characteristics (age, sex, ECOG, histology, PD-L1, AGA status); treatment assignment and exposure (dates offset, doses, modifications); efficacy outcomes and dates (tumor measurements, RECIST/iRECIST responses, PFS, OS, DOR, DCR); safety data (AEs/SAEs with MedDRA codes, CTCAE grade, relatedness); lab results, vitals/ECGs, concomitant meds; processed biomarker datasets and derived pathology/image features. Raw direct identifiers and physical specimens require separate agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drug: Nogapendekin alfa inbakicept (NAI), Pembrolizumab and Cisplatin or Carboplatin in people with NSCLC (Advanced Non-small Cell Lung Cancer) and Metastatic NSCLC, run by ImmunityBio, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) by BICR (RECIST v1.1) (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.