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Adjuvant chemotherapy with optional cemiplimab plus short-course sequential radiotherapy for unfit or elderly patients with stage III non-small cell lung cancer

A Multicenter Randomized Open Label Phase II Study Evaluating the Efficacy and the Tolerance of Immunochemotherapy and of Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Unresectable Stage III Non Small Cell Lung Cancer

Phase 2 Interventional Intergroupe Francophone de Cancerologie Thoracique · NCT06656598

This tests whether adding the immunotherapy cemiplimab to carboplatin‑paclitaxel chemotherapy and sequential short-course radiotherapy helps unfit or elderly people with unresectable stage III non-small cell lung cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment152 (estimated)
Ages18 Years and up
SexAll
SponsorIntergroupe Francophone de Cancerologie Thoracique Academic / other
Drugs / interventionschemotherapy, Immunotherapy, prednisone
Locations25 sites (Angers and 24 other locations)
Trial IDNCT06656598 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional protocol enrolls adults with unresectable stage III NSCLC who are elderly or considered unfit for standard concurrent chemoradiation. Participants receive carboplatin plus paclitaxel chemotherapy followed by curative hypofractionated radiotherapy, with some participants also receiving cemiplimab during treatment and as maintenance. Outcomes include measures of disease control and survival with standard radiologic and clinical follow-up. Eligibility targets older patients (≥70 with ECOG 0–1) or younger patients with significant comorbidity or ECOG 2 and requires measurable unresectable stage III disease.

Who should consider this trial

Good fit: Adults with unresectable stage III NSCLC who are elderly (≥70 with ECOG 0–1) or younger patients who are unfit (ECOG 2 or high comorbidity) and who can tolerate carboplatin, paclitaxel, immunotherapy, and hypofractionated radiotherapy.

Not a fit: Patients who are fit for standard concurrent chemoradiation, have resectable disease, or who cannot receive immunotherapy, platinum‑based chemotherapy, or radiotherapy are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, adding cemiplimab could improve disease control and survival while using a shorter radiotherapy schedule better suited to older or frail patients.

How similar studies have performed: Other trials adding PD‑1/PD‑L1 immunotherapy around chemoradiation—most notably durvalumab after chemoradiation—have improved outcomes in stage III NSCLC, but using cemiplimab with adjuvant chemotherapy and hypofractionated radiotherapy in this specific unfit or elderly population is less well-studied.

Eligibility criteria

Show full inclusion / exclusion criteria 
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. Patients over 70 years of age with Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS of 0 to 1.

   Or Patients under 70 years of age with ECOG PS of 0 to 1 and a score ≥ 3 according to the Charlson comorbidity criterion or ECOG PS 2.
6. Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee.
7. Measurable disease according to RECIST 1.1.
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.

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. Patients with an 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 less than 3 years old or progressive (except basal cell carcinoma of the skin and carcinoma in situ of the uterus).
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.

Where this trial is running

Angers and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Stage III NSCLCNSCLCNSCLC, Stage IIIUnfit or elderly patientsIFCT
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.