A Phase 3 interventional study of Radical local treatment and SoC-based immunotherapy (+/- chemotherapy) in Oligometastatic Non-small Cell Lung Cancer (NSCLC), sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Recruiting at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Phase 3, Interventional, and Treatment
First-line immunotherapy-based standard of care and local ablative treatments for oligometastatic non-small cell lung cancer patients: a randomized, multicentre, open-label phase III study
Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
RLT of all metastatic sites should be administered within 3 months after randomization and should not delay SoC-based immunotherapy administration.
Radiation: Radical local treatment · Drug: SoC-based immunotherapy (+/- chemotherapy)
SoC-based immunotherapy (+/- chemotherapy) will be administered every 3 weeks
Drug: SoC-based immunotherapy (+/- chemotherapy)
RLT of all metastatic sites. The possible RLT options will be SBRT, interventional radiology and/or minimally invasive surgery. Depending on the metastatic site, access and patient condition, the best RLT should be initially discussed in a case-to-case basis at the local multidisciplinary board (MTB). The primary tumour and initially invaded lymph nodes should be treated during the maintenance phase. Curative-intent approach modalities (e.g. hypofractionated intensity-modulated thoracic radiation therapy or surgery) should be discussed at the local MTB.
Also known as: SBRT, Interventional radiology, Minimally invasive surgery
Current French SoC will be used. Main SoC-based immunotherapy includes: * Platinum-based chemotherapy combined with an anti PD-1 immunotherapy (pembrolizumab). Pemetrexed-platinum combinations may be used in non- squamous carcinoma, while paclitaxel-platinum combination is favoured in squamous carcinoma. * Anti PD-1 monotherapy if PD-L1 ≥ 50% is a possible alternative (pembrolizumab or atezolizumab or cemiplimab). Other alternatives include nivolumab-ipilimumab-chemotherapy or durvalumab-tremelimumab-chemotherapy association. Bevacizumab is not allowed given possible interactions with RLT. Maintenance/Immunotherapy alone will be pursued at the investigator's discretion according to the standard procedures (toxicity, progression, choice of the patient...).
Overall Survival (OS).
Time from randomization to the date of documented death from any cause or last follow-up.
Time frame: From date of randomization up to two years after the randomization of the last patient or documented death.
Progression-free survival (PFS) according to RECIST 1.1.
Time between the randomization date and the date of observation of a progression of the disease according to RECIST 1.1 or death of the patient (all causes combined) or date of last follow-up if the patient is alive without progression or lost to follow up.
Time frame: From date of randomization up to two years after the randomization of the last patient or documented death.
immune Progression-free survival (iPFS) according to iRECIST.
Time between the randomization date and the date of observation of an progression of the disease according to iRECIST 1.1 or death of the patient (all causes combined) or date of last follow-up if the patient is alive without progression or lost to follow up.
Time frame: From date of randomization up to two years after the randomization of the last patient or documented death.
Number of side effects measured by CTCAE V.5.
Acute/ late adverse events graded by CTCAE v5 (toxic death and serious adverse events) and their imputability to treatment.
Time frame: From date of randomization up to two years after the randomization of the last patient or documented death.
EORTC Quality of Life Questionnaire-C30 (EORTC QLQ-C30).
The EORTC Quality of Life Questionnaire-C30 (EORTC QLQ-C30) contains 30 questions and assesses the quality of life of oncological patients multidimensionally over 10 subscales. All sub-scales and the 6 individual items have a score range from 0 to 100 points. A higher score represents better function and a higher quality of life. In the symptom subscale, however, a higher score represents a higher level of symptoms or problems.
Time frame: From date of randomization up to 24 months after the last patient included in the study, until the date of first documented progression or date of death from any cause, whichever come first.
EORTC Quality of Life Questionnaire Lung Cancer-specific-13 (QLQ-LC-13).
EORTC Quality of Life Questionnaire Lung Cancer-specific-13 (QLQ-LC-13) is a specific companion module used in conjunction with the EORTC QLQ-C30 and specifically developed for patients with Lung Cancer, and reliable in LC specific Qol assessment. The EORTC QLQ-LC13 comprises 13 item that measure lung cancer-related symptoms. Each items use the same 1-to-4 verbal response scale as the QLQ-C30 items, and domain scores are also transformed to a 0-to-100 metric. A higher score represents better function and a higher quality of life.
Time frame: From date of randomization up to 24 months after the last patient included in the study, until the date of first documented progression or date of death from any cause, whichever come first.
EuroQol-5D-5L Questionnaire (EQ-5D-5L).
The EuroQol-5D-5L Questionnaire (EQ-5D-5L) descriptive system of 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0. Used alongside the EQ-5D, the EQ visual analog scale (VAS) is a 20 cm VAS "assessing your own health today" with endpoints labeled "Best imaginable health state" (100) and "Worst imaginable health state" (0).
Time frame: From date of randomization up to 24 months after the last patient included in the study, until the date of first documented progression or date of death from any cause, whichever come first.
Clearance of circulating tumour DNA (ctDNA).
ctDNA assessed in plasma.
Time frame: At the randomization, then Week 6 and Month 4 after randomization.
Economic evaluation.
Incremental cost per Quality-adjusted life year (QALY based on EQ-5D-5L measures), incremental net monetary benefit. Assess the cost-utility (cost per QALY) of RLT + immunotherapy-based SoC compared to immunotherapy-based SoC alone.
Time frame: From date of randomization up to 24 months after the last patient included in the study, until the date of first documented progression or date of death from any cause, whichever come first.
Plan to share: No
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Gustave Roussy, Cancer Campus, Grand Paris