A Phase 2 interventional study of N-803 + Pembrolizumab and N-803 + Nivolumab in Non-Small Cell Lung Cancer, Small Cell Lung Cancer and Urothelial Carcinoma, sponsored by ImmunityBio, Inc.. Active, not recruiting at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by ImmunityBio, Inc. · Phase 2, Interventional, and Treatment
QUILT-3.055 is a Phase 2b, open-label, multicohort study investigating combination immunotherapies in patients with advanced solid tumors who have previously been treated with PD-1/PD-L1 checkpoint inhibitors. The study aims to evaluate the safety and efficacy of NAI (nogapendekin alfa inbakicept) in combination with other agents like checkpoint inhibitors and cell therapies across various cancer types and treatment settings. The study includes multiple cohorts based on prior therapies and cancer types, with a focus on assessing overall response rate (ORR), overall survival (OS), and other measures of anti-tumor activity and immune response.
All cohorts are closed to enrollment
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →ImmunityBio, Inc. is the lead sponsor of 83 studies on the registry; 15 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 17 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have received exactly 1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced disease (stage IV or recurrent disease, or stage I-III disease in certain circumstances) outlined below. Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy.
a. For those participants who received , adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy for stage
I-III disease:
If they had disease progression within (≤) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease OR if they had disease progression more than (>) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy, this is not considered anti-PD-1 or anti-PD-L1 therapy for advanced disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease.
EXCLUSION CRITERIA (Cohort 6 only)
Inadequate organ function, evidenced by the following laboratory results:
Have any of following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with any of the cancers listed below who have progressed on or after single-agent checkpoint inhibitor therapy after experiencing an initial complete response (CR) or partial response (PR) while taking a checkpoint inhibitor. 1a - Non-small cell lung cancer 1b - Small cell lung cancer 1c - Urothelial carcinoma 1d - Head and neck squamous cell carcinoma 1e - Merkel cell carcinoma 1f - Melanoma 1g - Renal cell carcinoma 1h - Gastric cancer 1i - Cervical cancer 1j - Hepatocellular carcinoma 1k - Microsatellite instability-high or mismatch repair deficient solid tumor cancer or colorectal cancer
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab · Drug: N-803 + Atezolizumab · Drug: N-803 + Avelumab · Drug: N-803 + Durvalumab
Patients with NSCLC whose tumors have high PD-L1 expression (TPS ≥ 50%) and who relapsed on a PD-1 checkpoint inhibitor after experiencing an initial CR or PR when they received checkpoint inhibitor as a single-agent for first-line treatment.
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab
Patients with NSCLC who had an initial CR or PR but subsequently relapsed on maintenance PD-1 checkpoint inhibitor therapy when they initially received checkpoint inhibitor therapy in combination with chemotherapy as first-line treatment.
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab
Patients who are currently receiving PD-1/PD-L1 checkpoint inhibitor therapy and have disease progression after experiencing stable disease (SD) for at least 6 months during their previous treatment with PD-1/PD-L1 checkpoint inhibitor therapy.
Drug: N-803 + Pembrolizumab · Drug: N-803 + Nivolumab · Drug: N-803 + Atezolizumab · Drug: N-803 + Avelumab · Drug: N-803 + Durvalumab
Patients that have experienced disease progression by Investigator-assessment per irRECIST while receiving treatment in Cohorts 1-4.
Drug: N-803 + Pembrolizumab + PD-L1 t-haNK · Drug: N-803 + Nivolumab + PD-L1 t-haNK · Drug: N-803 + Atezolizumab + PD-L1 t-haNK · Drug: N-803 + Avelumab + PD-L1 t-haNK · Drug: N-803 + Durvalumab + PD-L1 t-haNK
Patients who have progressed after an initial response (CR or PR) to a PD-1/PD-L1 checkpoint inhibitor but now exhibit acquired resistance. They have received exactly one line of anti-PD-1 or anti-PD-L1 therapy (either pembrolizumab or nivolumab) for advanced NSCLC (Stage IV or recurrent).
Drug: N-803 + Docetaxel + Pembrolizumab · Drug: N-803 + Docetaxel + Nivolumab
Drug pages: Nogapendekin alfa inbakicept · Pembrolizumab
Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Drug pages: Nogapendekin alfa inbakicept · Nivolumab
Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Drug pages: Nogapendekin alfa inbakicept · Atezolizumab
Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Drug pages: Nogapendekin alfa inbakicept · Avelumab
Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Drug pages: Nogapendekin alfa inbakicept · Durvalumab
Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at \~2 x 10\^9 cells/dose weekly
Drug pages: Nogapendekin alfa inbakicept · Docetaxel · Pembrolizumab
The study employs a 6-week cycle combination of: N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and pembrolizumab (200 mg IV).
Drug pages: Nogapendekin alfa inbakicept · Docetaxel · Nivolumab
The study employs a 6-week cycle combination of:N-803 (1.2 mg flat dose SC), docetaxel (75 mg/m² IV - first 2 cycles only), and nivolumab (240 mg IV). Nivolumab dosing may be increased to 480mg every four weeks as per the investigator's discretion.
ORR, defined as Investigator-assessed CR + PR per RECIST v1.1.
ORR reflects tumor shrinkage and is the key measure of antitumor activity.
Time frame: Evaluated from the first dose of study drug and repeated at each scheduled disease-assessment visit for up to 24 months (or until progression/death), with the time-to-response summarized using Kaplan-Meier methods
Prolongation of OS with NAI therapy by ALC response, where: - OS is defined as the time from first study drug administration to death resulting from any cause. - ALC response is defined as achievement or maintenance of an on-treatment ALC ≥ 1,000 cells/μ
OS is the gold-standard efficacy endpoint; the protocol explores whether an ALC rise predicts a survival benefit.
Time frame: Measured from the date of the first study-drug administration to the date of death (any cause) and followed for up to 24 months after the last dose (or until death), allowing the correlation with on-treatment ALC changes
ALC response to NAI therapy
Defined as achieving a mean on-treatment absolute lymphocyte count (ALC) ≥ 1,000 cells/µL.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of follow-up, assessed up to 24 months.
Prolongation of therapy
Measured as the time on NAI treatment, analyzed according to whether the participant attained the ALC response described above.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Overall survival (OS) for all patients and subgroups
Defined as the time from the first study-drug administration to death from any cause.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Disease-specific survival (DSS)
Time from first study drug administration to death resulting from cancer.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Progression-free survival (PFS)
Time from the first study-drug administration to either documented disease progression or death from any cause, whichever occurs first
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Time to response
The interval from the first dose of study drug to the first documented objective tumor response (CR or PR)
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Duration of response (DoR)
Time from the date of documented response (CR or PR) until disease progression or death.
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Disease Control Rate (DCR):
measures the percentage of patients with stable disease (SD), partial response (PR), or complete response (CR). It indicates the proportion of patients who experience benefit from the treatment in terms of disease stabilization or tumor shrinkage.
Time frame: Assessed at the end of each 6-week cycle (each cycle = 42 days) through 2 years (up to Cycle 17)
Quality of life (QoL) - Assessed in cohorts 1-5 only.
Assesses patient well-being using standardized questionnaires like EORTC QLQ-C30/LC13 or FACT PRO (module-specific), each with varying scales where higher scores generally indicate better functioning (but may also mean more symptoms).
Time frame: From the date of first study-drug administration until the earlier of death or the planned end of study follow-up, assessed up to 24 months after the last dose of study drug.
Physical examinations
A full physical exam is conducted to assess any new or worsening clinical findings.
Time frame: Baseline (screening), Day 1 (first dose), and prior to every subsequent NAI dose (e.g., every 2 weeks), then at each post-treatment safety visit (Week 12, Week 24, Week 36, Week 48, and at end-of-study visit)
Incidence of TEAEs and SAEs
All treatment-emergent adverse events and serious adverse events are recorded and graded using the NCI Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Captured continuously from the first dose of study drug and monitored at every study visit throughout the treatment period and the post-treatment follow-up phase (until study closure, typically up to ~24 months after the last dose).
Laboratory tests
Routine hematology, chemistry, and other safety-related labs are performed to detect treatment-related abnormalities.
Time frame: Baseline, Day 1, on-treatment (prior to each dose; every 2 weeks), and at each post-treatment safety visit (Week 12, Week 24, Week 36, Week 48, and end-of-study)
Vital signs
Blood pressure, heart rate, respiratory rate, temperature, and weight are recorded.
Time frame: Baseline, Day 1, before each NAI infusion (typically every 2 weeks), and at all scheduled safety follow-up visits (Week 12, Week 24, Week 36, Week 48, and final study visit)
ORR (Objective Response Rate)
Cohorts 1-5 (irRECIST) Proportion of participants achieving a confirmed complete or partial response per immune-related RECIST.
Time frame: Assessed from the first dose onward at scheduled tumor-assessment visits (typically every 8-12 weeks) until progression, death, or study end (≈ 24 months).
PFS (Progression-Free Survival)
Cohorts 1-5 (irRECIST) Time from first dose to disease progression (per irRECIST) or death from any cause, whichever occurs first.
Time frame: From Day 1 of first study-drug administration to first documented disease progression (per irRECIST/iRECIST) or death from any cause, whichever occurs first, assessed up to 24 months.
Time to response
Cohorts 1-5 (irRECIST) Interval from first dose to the first documented objective response (CR or PR)
Time frame: From Day 1 of first study-drug administration to the date of first confirmed complete or partial response, assessed up to 24 months.
DCR (Disease-Control Rate)
Cohorts 1-5 (irRECIST) Proportion of participants achieving CR, PR, or stable disease per irRECIST.
Time frame: Assessed at each tumor-assessment visit (baseline, Week 8 ± 1, Week 16 ± 2, Week 24 ± 2, and thereafter every 12 weeks) through 24 months.
DoR (Duration of Response)
Cohorts 1-5 (irRECIST) Time from first documented response to disease progression or death.
Time frame: From the date of first confirmed response to subsequent disease progression or death, whichever occurs first, assessed up to 24 months.
Immunogenicity profile
Cohorts 1-5 (irRECIST) Detection of anti-drug antibodies or other immune responses to the investigational agents.
Time frame: Blood sampled at baseline, Day 1, Week 4, Week 12, and then every 12 weeks up to 24 months.
Cmax - Maximum plasma concentration of the investigational agent
The highest observed plasma concentration of the study drug after a single intravenous infusion, expressed in ng · mL-¹. Concentrations are measured using a validated LC-MS/MS assay (lower limit of quantitation = 1 ng · mL-¹).
Time frame: Assessed on Cycle 1 Day 1 (each cycle = 28 days) and Cycle 2 Day 1. Sampling schedule on each study day: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours post-dose
Tmax - Time to maximum plasma concentration of the investigational agent
Time elapsed from the start of the infusion to the occurrence of Cmax, expressed in hours. Determined from the same plasma-sampling schedule used for Cmax.
Time frame: Assessed on Cycle 1 Day 1 (each cycle = 28 days) and Cycle 2 Day 1. Sampling schedule on each study day: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours post-dose
AUC₀-t - Exposure (area under the plasma-concentration-time curve) from time 0 to the last quantifiable concentration
Calculated using the linear-trapezoidal method applied to the concentration-time data obtained from the intensive sampling schedule (pre-dose through 24 h) on Cycle 1 Day 1. Units are ng · h · mL-¹.
Time frame: Assessed on Cycle 1 Day 1 (each cycle = 28 days) and Cycle 2 Day 1. Sampling schedule on each study day: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours post-dose
AUC₀-τ - Steady-state exposure over one dosing interval
Area under the plasma-concentration-time curve over a full dosing interval (τ) at steady state, calculated by the linear-trapezoidal method using pre-dose and post-dose samples collected on Cycle 2 Day 1 (or the first cycle where steady state is confirmed). Units: ng · h · mL-¹.
Time frame: Assessed on Cycle 2 Day 1 (each cycle = 42 days). Intensive sampling: pre-dose, end-of-infusion, 0.5 hour, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours post-dose. Sparse samples at weeks 12, 24, 36, 48, 60, 72, 84 (up to 24 months).
t½ - Terminal elimination half-life of the investigational agent
The time required for the plasma concentration to decline by 50 % during the terminal phase, calculated by log-linear regression of the last ≥3 measurable concentrations from the intensive sampling (typically 4 h, 8 h, 24 h) on Cycle 1 Day 1. Reported in hours.
Time frame: Determined from the same Cycle 1 Day 1 intensive sampling. No additional time points are required; the parameter is reported once per participant. The overall data-collection window for the participant is up to 24 months from first dose
ORR (Objective Response Rate)
Cohort 6 (iRECIST) Proportion of participants who achieve a confirmed complete response (CR) or partial response (PR) as assessed by the investigator using iRECIST criteria.
Time frame: Assessed from the first study-drug administration onward at scheduled tumor-assessment visits (typically every 8-12 weeks) and reported at the end of the follow-up period (up to the study's planned closure, e.g., ~24 months).
PFS (Progression-Free Survival)
Cohort 6 (iRECIST) Time from the first dose of study drug to the first occurrence of disease progression (per iRECIST) or death from any cause, whichever comes first.
Time frame: From Day 1 of first study-drug administration to first documented disease progression (per irRECIST/iRECIST) or death from any cause, whichever occurs first, assessed up to 24 months.
Time to response
Cohort 6 (iRECIST) - Interval between the first study-drug administration and the date of the first documented objective response (CR or PR) per iRECIST.
Time frame: From Day 1 of first study-drug administration to the date of first confirmed complete or partial response, assessed up to 24 months
DCR (Disease-Control Rate)
Cohort 6 (iRECIST) - Proportion of participants who achieve CR, PR, or stable disease (SD) according to iRECIST.
Time frame: Assessed at each tumor-assessment visit (baseline, Week 8 ± 1, Week 16 ± 2, Week 24 ± 2, and thereafter every 12 weeks) through 24 months
DoR (Duration of Response)
Cohort 6 (iRECIST) Time from the date of the first documented response (CR or PR) until disease progression (per iRECIST) or death, whichever occurs first.
Time frame: From the date of first confirmed response to subsequent disease progression or death, whichever occurs first, assessed up to 24 months.
Plan to share: No
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Started Dec 2018 (actual). Primary completion is estimated for Aug 2029, 128 months after the start.
Of 317 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's planned 128 months is above that.
Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Nogapendekin alfa inbakicept · Pembrolizumab · Nivolumab · Atezolizumab · Avelumab · Durvalumab · Docetaxel
Carcinoma, Non-Small-Cell Lung →