Lung cancer
Conditions
Interventions
The study doctor has the option to skip cycle 1 and start your anticancer
treatment at the same time as radiotherapy at cycle 2.
Arm A:
* CCRT Period: Nivolumab (360 mg flat dose IV Q3W) for cycles
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) ECOG performance status
Exclusion criteria
Exclusion criteria: 1) Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator, would preclude the patient from adhering to the protocol or would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results (eg, a condition associated with diarrhea or acute diverticulitis) 2) Active infection requiring systemic therapy within 14 days prior to randomization 3) Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie. participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease). Participants with history of prior early stage basal /squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are also eligible. 4) Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders(such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll 5) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease 6) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways 7) Presence of pleural/pericardial effusion on CT scan and/or X-ray. Effusions that are too small to be tapped safely are acceptable 8) Participants with EGFR mutation regardless of mutation type are excluded. Non-squamous tumour with unknown EGFR mutation status must be tested for EGFR mutation. 9) Known ALK translocation and/or ROS1 rearrangement 10) History of organ or tissue transplant that requires systemic use of immune suppressive agents 11) Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 12) Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening. Symptoms must have resolved and based on investigator assessment in consultation with the medical monitor, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment. 13) Prior/Concomitant Therapy a) Prior thoracic radiotherapy. Exceptions are prior radiotherapies involving the chest for clinical conditions other than lung cancers (eg, breast cancer) of which the radiation field does not overlap with that of the disease under study AND does not have FDG uptake at the previously irradiated area of the lung per the PET scan performed during screening. All other prior radiotherapy is allowed and must be completed at least 30 days prior to study treatment with
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are: * PFS by RECIST 1.1 per Blinded Independent Central Review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are: • OS for Arm A vs Arm C • PFS by RECIST 1.1 per BICR for Arm B vs Arm C • OS for Arm B vs Arm C • PFS by RECIST 1.1 per BICR for Arm A vs Arm B • OS for Arm A vs. Arm B • Objective Response Rate (ORR) by RECIST 1.1 per BICR • Duration of Response by RECIST 1.1 per BICR • Time to Response (TTR) by RECIST 1.1 per BICR • PFS by RECIST 1.1 per Investigator assessment • ORR by RECIST 1.1 per Investigator assessment • DoR by RECIST 1.1 per Investigator assessment • TTR by RECIST 1.1 per Investigator assessment • TTDM by RECIST 1.1 per Investigator assessment • Incidence of AEs, SAEs, and select AEs • Proportion of participants without meaningful symptom deterioration following 48 weeks of maintenance therapy based on LCS subscale of FACT-L and NSCLC-SAQ | — |
Countries
Netherlands
Outcome results
None listed