New combo therapy aims to boost survival in elderly lung cancer patients
NCT ID NCT06656598
First seen Jun 26, 2026 · Last updated Aug 12, 2026 · Updated 3 times
Summary
This study tests whether giving immunotherapy (Cemiplimab) along with chemotherapy (Carboplatin and Paclitaxel) before radiation can help elderly or unfit patients with stage III non-small cell lung cancer live longer without their cancer getting worse. The trial will enroll 152 participants and compare this approach to standard care. The goal is to improve survival while keeping side effects manageable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Carboplatin, Paclitaxel, Cemiplimab (Libtayo), and hypofractionated radiotherapy
- What this could lead to
- If successful, this could offer a more effective treatment option for elderly or unfit patients with stage III lung cancer, potentially improving survival without the need for more aggressive therapy.
- What could go wrong
- This is an early Phase 2 trial with only 152 participants, so results may not apply to all patients. The combination of drugs and radiation may cause side effects like fatigue, low blood counts, or immune-related reactions.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 152 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 subject care. 2. Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing. 3. Age ≥ 18 years. 4. Histologically or cytologically confirmed locally advanced non small cell lung cancer (NSCLC) stage IIIA non resectable, IIIB or IIIC accordingly to 8th classification TNM, UICC 2015. 5. Unfit or elderly patients as defined below: * ≥ 70 years , PS 0 to 1, charlson comorbidity criterion : all score * \< 70 years , PS 0 to 1, charlson comorbidity criterion : score ≥ 3 * \< 70 years , PS , charlson comorbidity criterion : all score 6. Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee. 7. Measurable disease according to RECIST 1.1 per investigator assessment. The radiological assessment has to be done within the timelines indicated. 8. Respiratory function: * FEV1 ≥ 40% of theoretical value, * DLCO ≥ 40%. 9. Bone marrow function: * absolute neutrophil count (ANC) ≥ 1.5.109/L, * platelets ≥ 100.109/L, * hemoglobin ≥ 9 g/dl. 10. Renal and hepatic function: * estimated creatinine clearance ≥ 45 ml/min, * bilirubin ≤1.5xULN, * AST ALT ≤3xULN, * Albumin ≥28g/dl. 11. Participant has national health insurance coverage. 12. Effective method of contraception during the treatment and during the 6 months following the last dose for patients of childbearing potential and for male subjects who are sexually active with a woman of childbearing potential. 13. Expression of PD-L1 as assessed locally by the investigator center. Exclusion Criteria: 1. Immunotherapy or chemotherapy contra-indicated. 2. Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee. 3. Stage I or II NSCLC. 4. Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC. 5. Histology other than primary non-small cell lung cancer. 6. Known activating EGFR mutation or ALK or ROS1 translocation. 7. Metastatic NSCLC including brain metastasis. 8. Patients not eligible for curative radiotherapy (tumor extension, predictable dose constraints that cannot be met). 9. Severe uncontrolled comorbidities or severe intercurrent disease: acute coronary syndrome less than 3 months old, unstable angina, heart failure with LVEF ≤30%, uncontrolled hypertension, Child B or C cirrhosis, severe sepsis, myocarditis or any other active conditions that would contraindicate chemotherapy, immunotherapy, or radiotherapy in the opinion of the investigator. 10. Weight loss ≥15% of total body weight in the last 6 months. 11. ECOG PS upper 2 12. Active autoimmune pathology. History of autoimmune pathology including myasthenia, Guillain-Barre syndrome, lupus erythematosus, antiphospholipid syndrome, Wegener's granulomatosis, glomerulonephritis, inflammatory bowel disease, vasculitis, sarcoidosis, uveitis. Autoimmune thyroid pathologies under replacement therapy as well as type 1 diabetes under insulin are authorized. 13. History of idiopathic pulmonary fibrosis, organized pneumopathy or signs of active interstitial pulmonary pathology on CT scan. 14. Any immunosuppressive therapy received within 28 days and corticosteroids \> 10mg/day of prednisone or equivalent received within 7 days prior the start of chemotherapy excepted hydrocortisone replacement for adrenal insufficiency or pituitary disease not considered immunosuppressive therapy. 15. Chronic active infection including tuberculosis, HIV, hepatitis B (HBsAg positive) or C. Patients with a history of cured hepatitis B (anti HBc and absence of negative HBs antigen) are eligible. In case of hepatitis C (anti HCV Ac) patients are eligible if the HCV PCR is negative. 16. Severe infections (including covid-19 infection) within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia. 17. History of neoplastic disease (other than NSCLC) less than 3 years old or progressive (except basal cell carcinoma of the skin and carcinoma in situ of the cervix). 18. History of thoracic radiotherapy. 19. Live attenuated vaccine received within 28 days of starting chemotherapy 20. History of organ or bone marrow transplantation. 21. Major surgery within 4 weeks of starting treatment. 22. Patient already included in another therapeutic trial. 23. Positive pregnancy test or breastfeeding woman. 24. Protected adults (under guardianship or curatorship). 25. Inability to undergo medical monitoring of the study (for geographical, social and/or physical reasons). 26. Patients unable to understand the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
25 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Locations
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Angers - CHU
RECRUITINGAngers, France
Contact Email: •••••@•••••
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Angers - Centre Paul Papin
RECRUITINGAngers, France
Contact Email: •••••@•••••
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Avignon - CH
RECRUITINGAvignon, France
Contact Email: •••••@•••••
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Bordeaux - CHU
RECRUITINGPessac, France
Contact Email: •••••@•••••
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Boulogne - Ambroise Paré
RECRUITINGBoulogne, France
Contact Email: •••••@•••••
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Brest - CHU
RECRUITINGBrest, France
Contact Email: •••••@•••••
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Caen - CHU
RECRUITINGCaen, France
Contact Email: •••••@•••••
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Caen - CRLCC
RECRUITINGCaen, France
Contact Email: •••••@•••••
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Créteil - CHI
RECRUITINGCréteil, France
Contact Email: •••••@•••••
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Dijon - CRLCC
RECRUITINGDijon, France
Contact Email: •••••@•••••
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Le Mans - CHG
RECRUITINGLe Mans, France
Contact Email: •••••@•••••
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Lille - CRLCC
RECRUITINGLille, France
Contact Email: •••••@•••••
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Lyon - HCL
RECRUITINGPierre-Bénite, France
Contact Email: •••••@•••••
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Marseille - APHM
RECRUITINGMarseille, France
Contact Email: •••••@•••••
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Mulhouse - GHRMSA
RECRUITINGMulhouse, France
Contact Email: •••••@•••••
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Nantes - CRLCC
RECRUITINGSaint-Herblain, France
Contact Email: •••••@•••••
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Paris - Bichat
RECRUITINGParis, France
Contact Email: •••••@•••••
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Paris - Hôpital Cochin
RECRUITINGParis, France
Contact Email: •••••@•••••
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Paris - Tenon
RECRUITINGParis, France
Contact Email: •••••@•••••
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Rennes - CHU
RECRUITINGRennes, France
Contact Email: •••••@•••••
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Rouen - Centre Henri Becquerel
RECRUITINGRouen, France
Contact Email: •••••@•••••
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Strasbourg - CRLCC
RECRUITINGStrasbourg, France
Contact Email: •••••@•••••
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Toulouse - CHU
RECRUITINGToulouse, France
Contact Email: •••••@•••••
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Tours - CHU
RECRUITINGTours, France
Contact Email: •••••@•••••
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Vandoeuvre-lès-Nancy - CRLCC
RECRUITINGVandœuvre-lès-Nancy, France
Contact Email: •••••@•••••
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