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Clinical Trials/2023-503326-39-00
2023-503326-39-00RecruitingPhase 3

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 (OliGRAIL)

Institut Gustave Roussy13 sites in 1 country130 target enrollmentStarted: November 19, 2024Last updated:
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Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
130
Locations
13
Primary Endpoint
The primary endpoint is overall survival (OS).
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To demonstrate the survival benefit of adding a radical local treatment (RLT) on a maximum of 5 secondary lesions in non-small cell lung cancer (NSCLC) patients receiving standard of care (SoC)-based immunotherap

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Histologically proven advanced synchronous oligometastatic stage IV NSCLC.
  • •Patient should understand, sign, and date the informed consent form written in French prior to any protocol-specific procedures performed.
  • •Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 6 months after completing treatment/therapy.
  • •Patients affiliated to the social security system.
  • •Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations including follow-up.
  • •Aga > 18 years
  • •NSCLC patients eligible first line immunotherapy-based SoC according to the European Marketing Authorization. PDL1 status available.
  • •Metastases eligible to RLT according to the local multidisciplinary board (MTB): ≤5cm each in CT scan, excluding primary tumour.
  • •Maximum 5 metastases in 3 organs (EORTC criteria), according to brain MRI and FDG-PET
  • •Symptomatic lesions requiring urgent palliative radiation, is permitted prior to randomization. These treated lesions should be counted towards the total number of metastases at the time of enrolment.
  • •Clinically required brain metastases (BM) ablation (surgery and/or SBRT) is permitted and BM count within the total number of 5 lesions. The patient would then be randomized to treatment of their extracranial disease
  • •Acceptable organ function for RLT
  • •ECOG performance status (PS) 0-1.

Exclusion Criteria

  • •Non-squamous NSCLC with targetable tumour mutations and approved first line targeted therapy (such as EGFR, ALK and ROS1).
  • •Metastases not eligible to RLT: e.g. brainstem or diffuse serosal metastases (meningeal, pericardial, pleural, peritoneal, mesenteric) or that invades the gastrointestinal tract.
  • •Brain metastases only, without extra-cerebral metastases
  • •Uncontrolled severe comorbidity, symptomatic interstitial lung disease or active infection.
  • •Prior therapy with T-cell costimulation or immune checkpoint-targeted agents within 1 year.
  • •Uncontrolled concomitant (<1-year) malignancy except adequately treated basal or squamous cell carcinoma of the skin, or in-situ carcinoma of any organ or in-situ melanoma of the skin.

Outcomes

Primary Outcomes

The primary endpoint is overall survival (OS).

The primary endpoint is overall survival (OS).

Secondary Outcomes

  • PFS or iPFS according to RECIST 1.1 and iRECIST.
  • Cancer specific survival.
  • Type of relapses, local and distant control rates in both arms.
  • Acute/ late adverse events graded by CTCAE v5 (toxic death and serious adverse events).
  • QoL according to EORTC QLQ-C30, QLQ-LC-13, EQ-5D-5L
  • Clearance rate at 6 weeks and 4 months (before maintenance) of circulating tumour DNA assessed in plasma compared to value at baseline in the 2 arms.
  • Economic evaluation: incremental cost per Quality-adjusted life year (QALY based on EQ-5D-5L measures), incremental net monetary benefit.

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Chargée d'affaires réglementaires

Scientific

Institut Gustave Roussy

Study Sites (13)

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