BridgeMD
Personnalized immunotherapy in patients with stage III non-small cell lung cancer
EU CTIS ID: 2025-522801-39-00
What this study is testing
To evaluate the efficacy of a personalized strategy of consolidation immunotherapy based on the assessment of MRD post-CRT in stage III NSCLC.
- 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
- Patients must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care. Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Creatinine clearance (according to the institution's standard method) ≥ 45 mL/min.
- For women of childbearing potential (including women who have had a tubal ligation), serum pregnancy test must be performed and documented as negative within 14 days prior to C1D1.
- Women of childbearing potential must remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drugs. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries or uterus). Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method plus spermicide. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Men with female partners of childbearing potential or pregnant female partners, must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Patient has national health insurance coverage.
You likely can't join if
- Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R or L861X mutations in exon 21, G719A/S mutation in exon 18, exon 20 insertion) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation).
- Pregnant or breast-feeding woman.
- Patient under legal protection.
- Patient unable to follow the constraints of the trial.
- Systemic corticosteroid therapy > 10mg/day of prednisone or equivalent and immunosuppressive treatment (with the exception of supplementary hydrocortisone treatment).
- History of autoimmune disease, with the exception of: Stable substituted hypothyroidism ; Balanced type 1 diabetes ; Vitiligo, psoriasis, lichen, without extra-dermatological involvement
See the full eligibility criteria
Who can join
- Patients must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care. Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
- Creatinine clearance (according to the institution's standard method) ≥ 45 mL/min.
- For women of childbearing potential (including women who have had a tubal ligation), serum pregnancy test must be performed and documented as negative within 14 days prior to C1D1.
- Women of childbearing potential must remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drugs. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries or uterus). Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method plus spermicide. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Men with female partners of childbearing potential or pregnant female partners, must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Patient has national health insurance coverage.
- Age ≥18 years.
- ECOG Performance Status of 0 or 1.
- Histologically proven unresectable locally advanced stage III NSCLC.
- Diagnostic tumor tissue sample available for molecular biology analysis.
- Measurable tumor according to RECIST1.1.
- Patient eligible for concomitant curative CRT with authorization of two course of induction chemotherapy before the start of CRT. The minimum dose of radiotherapy is 60 Gy over 95% of tumor volumes.
- FEV1≥40% of theoretical and PaO2≥60mmHg
- Hematological criteria: PNN ≥ 1.5x109/L and platelets ≥ 100x109/L, Hemoglobin ≥ 9 g/dL.
What rules you out
- Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R or L861X mutations in exon 21, G719A/S mutation in exon 18, exon 20 insertion) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation).
- Pregnant or breast-feeding woman.
- Patient under legal protection.
- Patient unable to follow the constraints of the trial.
- Systemic corticosteroid therapy > 10mg/day of prednisone or equivalent and immunosuppressive treatment (with the exception of supplementary hydrocortisone treatment).
- History of autoimmune disease, with the exception of: Stable substituted hypothyroidism ; Balanced type 1 diabetes ; Vitiligo, psoriasis, lichen, without extra-dermatological involvement
- History of anti-cancer treatment with immune checkpoint inhibitor.
- Known ALK, ROS1, gene rearrangement as assessed by immunohistochemistry, FISH or NGS (ADN or ARN) sequencing by local genetics and/or pathology laboratory.
- Sequential CRT, defined as the start of thoracic irradiation after the administration of the third course of chemotherapy.
- Pleural involvement or extra-thoracic tumor lesions.
- Comorbidity contraindicating CRT.
- Significant lesions of interstitial lung disease on chest CT or proven interstitial lung disease.
- History of cancer in the last 3 years, or active cancer (with the exception of basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix).
- Previous thoracic radiotherapy.
- Previous chemotherapy in the last 3 years.
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, 65+ years, 18-64 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.