BridgeMD
Integrative analysis of the tumor microenvironment and optimization of the immunotherapy duration in non-small cell lung cancer patients.
EU CTIS ID: 2023-509490-23-00
What this study is testing
The primary objective is to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy). The long-term benefit of PD1/PDL-1 inhibition will be assessed in terms of progression-free rate (PFR) at 12 months after randomization, for each therapeutic strategy (in patients discontinuing treatment and in patients continuing treatment).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous).
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
- Patient with a social security in compliance with the French law (Loi Jardé).
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Voluntarily signed and dated written informed consent prior to any study specific procedure.
- Locally advanced/unresectable or metastatic disease.
You likely can't join if
- Female who is pregnant or breast-feeding.
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
- Hypersensitivity to one of the active substances or to one of the excipients
- Any contraindication to pursue ICI treatment as per investigator judgement.
- Previous enrolment in the present study.
- Individual deprived of liberty or placed under legal guardianship.
See the full eligibility criteria
- Histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous).
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.
- Patient with a social security in compliance with the French law (Loi Jardé).
- Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Voluntarily signed and dated written informed consent prior to any study specific procedure.
- Locally advanced/unresectable or metastatic disease.
- For non-squamous histology, tumor with no oncogenic addiction: no activating EGFR mutation, no ALK or ROS1 rearrangement,
- Treatment with ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy): a. in first or second-line treatment as per market authorization. For patients in first line, ICI alone or ICI + chemotherapy, b. start of ICI treatment 6 to 12 months (+/- 2 weeks) before registration.
- At least one measurable lesion according to the RECIST v1.1 criteria before ICI treatment onset and confirmed by centralized review (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally ≥ 10 mm.
- Patient with objective response (CR, PR) according to RECIST v1.1 criteria at 6 months or more and less than 12 months after ICI treatment onset. Response must be confirmed by centralized review on the basis of all CT scan carried out since the initiation of ICI treatment up to registration. PET-CT are also acceptable (several PET-CTs or CT scans compared with PET-CTs), under the following conditions: a. Target lesions must be evaluable on PET-CT according to RECIST v1.1. This will be determined by the centralized radiologist at the time of the review. If target lesions are not evaluable according to RECIST v1.1, patient will not be eligible. b. PET-CT is acceptable only for the centralized review. If not available, an additional CT scan must be performed within four weeks prior to registration (+1 week tolerance) to be used as baseline tumor assessment. Patient must be then followed using the same technique throughout the duration of the protocol.
- At least one lesion that can be biopsied for research purpose. Note that in case of complete response or too small size lesion, the investigator must ensure the availability of suitable paraffin embedded (FFPE) archived tumor material (primary or metastatic site).
- Age ≥ 18.
- Performance status < 2.
- Female who is pregnant or breast-feeding.
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
- Hypersensitivity to one of the active substances or to one of the excipients
- Any contraindication to pursue ICI treatment as per investigator judgement.
- Previous enrolment in the present study.
- Individual deprived of liberty or placed under legal guardianship.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.