Phase 2
N=105
Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03285321 ↗Enrolled (actual)
105
Serious AEs
29.5%
Results posted
Mar 2025
Primary outcome: Primary: Progression Free Survival (PFS) at 18-month — 65.5; 66.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab (Drug); Ipilimumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Greg Durm, MD
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) at 18-month |
65.5; 66.3 | — |
| SECONDARY Overall Survival (OS) |
32; NA | — |
| SECONDARY Time to Metastatic Disease (TTMD) at 36 Month |
79.7; 77.5 | — |
| SECONDARY Number of Participants With Adverse Events |
54; 51 | — |
Summary
This study is an open label, multicenter, randomized phase II trial of consolidation immunotherapy with either nivolumab alone or the combination of nivolumab and ipilimumab following concurrent chemoradiation in patients with unresectable stage III NSCLC.
Eligibility Criteria
Inclusion Criteria
Subject must meet all of the following applicable inclusion criteria to participate in this study:
- Written informed consent and HIPAA authorization for release of personal health information.
- Age ≥ 18 years at the time of consent.
- ECOG Performance Status of 0 or 1 within 14 days prior to registration.
- Histological or cytological confirmation of NSCLC. A pathology report confirming the diagnosis of NSCLC must be obtained and reviewed by the treating physician prior to registration to study.
- Must have unresectable or inoperable stage IIIA or IIIB disease according to the 7th edition IASLC stage classification for lung cancer. Subjects must be considered unresectable or inoperable based on the judgment of the treating physician.
- Subjects must have completed concurrent chemoradiation with a platinum doublet and a dose of radiation ranging from 59.4-66.6 Gy. Subjects must have stable disease or disease response as evidenced on CT or PET scan evaluation. For those eligible, protocol therapy should begin within 56 days of completing chemoradiation OR Subjects must have completed up to 2 cycles of consolidation therapy started within 56 days of completion of radiation. After completion of consolidation chemotherapy, subjects must have stable disease or disease response as evidenced by CT or PET scan evaluation. For those eligible, protocol therapy should begin within 56 days after the last cycle of chemotherapy.
- Prior cancer treatment must be completed between 1-56 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline.
- Demonstrate adequate organ function, all screening labs to be obtained within 14 days prior to registration:
Hematological:
- Absolute Neutrophil Count (ANC) ≥ 1.5 K/mm^3
- Hemoglobin (Hgb) ≥ 9 g/dL
- Platelets ≥100,000/mcl
Renal:
- Serum creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5 x upper limit of normal (ULN) OR ≥ 60 mL/min for subjects with creatinine levels >1.5 x institutional ULN
Hepatic:
- Bilirubin ≤ 1.5 × ULN OR Direct bilirubin of ≤ ULN for subjects with total bilirubin levels of >1.5x ULN
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Coagulation:
- International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT/INR/PTT is within therapeutic range of intended use of anticoagulants
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 7 days prior to registration. NOTE: Women are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are post-menopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to be considered post-menopausal.
- Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception from the time of informed consent until 23 weeks after treatment discontinuation.
- Men who are sexually active with women of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year. Men receiving study drug and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedu
Data sourced from ClinicalTrials.gov (NCT03285321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.