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Adjuvant Chemotherapy +/- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer

ConditionStage III NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntergroupe Francophone de Cancerologie Thoracique

About this trial

The use of neoadjuvant immuno-chemotherapy could improve survival outcomes of patients eligible for sequential radio-chemotherapy comparing to the benefit already obtained with maintenance immunotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.

Age ≥ 18 years.

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.

Disqualifiers

Immunotherapy or chemotherapy contra-indicated.

Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee.

Stage I or II NSCLC.

Previously received a treatment with anti-PD1/PDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    Neoadjuvant treatment with Carboplatin AUC 5 D1 (3 cycles of 4 weeks).

  • Paclitaxel

    Drug

    Neoadjuvant treatment with Paclitaxel 80mg/m² D1 (3 cycles of 4 weeks).

  • Cemiplimab

    Drug

    Neoadjuvant treatment with Cemiplimab (Libtayo®) 350 mg D1-D21 (3 cycles of 4 weeks).

  • Curative hypofractionated radiotherapy

    Radiation

    Curative hypofractionated radiotherapy (55 Gy/20fr) after the end of neoadjuvant treatment.

  • Cemiplimab (maintenance)

    Drug

    Maintenance immunotherapy with Cemiplimab 350 mg every 3 weeks after the end of radiotherapy (12 months).

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: Arm A (neoadjuvant chemotherapy only)Active comparator 4 interventions
Group B: Arm B (neoadjuvant chemo-immunotherapy)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

Time from randomization to progression or death.

Time frame
About 18 months

Secondary outcomes

1

Objective Response Rate (ORR)

Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR)

Time frame
About 18 months
2

Disease Control Rate (DCR)

Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)

Time frame
About 18 months
3

PFS at 12 months

Time from randomization to progression or death.

Time frame
At 12 months
4

PFS at 18 months

Time from randomization to progression or death.

Time frame
At 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intergroupe Francophone de Cancerologie Thoracique

Lead sponsor

Source ClinicalTrials.gov
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