Durvalumab Plus Etoposide-free Chemotherapy in First-line Treatment of Extensive-disease Small-sell Lung Cancer (SCLC)

NCT05856695 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: IFCT-2203
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 31

Brief Summary

The current study is intended to be a "proof of concept" to evaluate the potential value of synergy between paclitaxel carboplatin and immunotherapy. If a signal clearly shows superiority over the CASPIAN data , we will have arguments to think that the combination of paclitaxel and carboplatin is more suitable for synergy with immunotherapy than the standard etoposide and carboplatin.

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

IFCT; SCLC; SCLC Extensive Stage

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall Survival (OS) defined as the time from the date of first dose of study drug to the date of death due to any cause

  At 12 months

Secondary Outcomes (7)

• Best response rate (RECIST 1.1)

  About 48 months

• Overall Survival (OS)

  About 48 months

• Overall Survival (OS)

  At 24 months

• Overall Survival (OS)

  At 36 months

• Progression free survival (PFS)

  About 48 months

Study Arms (1)

Carboplatin + Paclitaxel + Durvalumab

EXPERIMENTAL

Carboplatin AUC 6, day 1 of three-week cycle for four cycles Paclitaxel 200 mg/m² day 1 of a three-week cycle for four cycles Durvalumab 1500 mg every 3 weeks for 4 cycles followed by 1500 mg maintenance every 4 weeks until progression, unacceptable toxicity, or consent withdrawal

Drug: Carboplatin + Paclitaxel + Durvalumab

Interventions

Carboplatin + Paclitaxel + Durvalumab DRUG

Carboplatin AUC 6, day 1 of three-week cycle for four cycles Paclitaxel 200 mg/m² day 1 of a three-week cycle for four cycles Durvalumab 1500 mg every 3 weeks for 4 cycles followed by 1500 mg maintenance every 4 weeks until progression, unacceptable toxicity, or consent withdrawal

Carboplatin + Paclitaxel + Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed consent.
• Subjects 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.
• Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.
• Patients diagnosed with histologically confirmed SCLC
• Extended-Stage Disease at time of accrual according to the criteria of the Veteran's Administration Lung Cancer Group (VALG). Extended disease is defined as going beyond hemithorax and supraclavicular ganglionic areas, and malignant pleural effusions will be considered extended diseases.
• At least one measurable target lesion according to RECIST v1.1 per investigator assessment.The radiological assessment has to be done within the timelines indicated.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 (see Appendix 1).
• Body weight \>30 kg.
• Adequate biological functions:
• Creatinine clearance ≥ 45 ml/min (Cockroft or MDRD or CKD-epi);
• Hemoglobin ≥ 9.0 g / dL
• Neutrophils ≥ 1500 /μL
• Platelets ≥ 100 000 /μL
• Bilirubin ≤ 1.5 x normal except for patients with proved Gilbert syndrome (≤ 3 x ULN)

You may not qualify if:

• Non-small cell lung cancer (NSCLC) or combined SCLC and NSCLC.
• Prior systemic anticancer therapy for SCLC.
• Radiotherapy needed at initiation of treatment.
• Major surgical procedure (as defined by the Investigator) within 28 days prior initiation of treatment.
• Note: Local surgery of isolated lesions for palliative intent is acceptable.
• Symptomatic brain metastasis. Note: patient with asymptomatic or treated and stable brain metastasis for at least 1 month prior to study treatment are eligible. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to study entry.
• History of leptomeningeal carcinomatosis.
• Symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, cardiac arrhythmia or clinically uncontrolled heart disease.
• Mean QT interval corrected (QTc) ≥470 ms.
• Corticosteroid therapy at a dose greater than 10 mg per day of prednisolone or equivalent for more than 10 days within 14 days prior initiation of treatment.
• Note: Intranasal, inhaled, topical steroids, or local steroid injections and steroids as premedication for hypersensitivity reactions are allowed.
• Serum sodium \<125 mmol/L unless corrective treatment prior to initiation of study treatment.
• Hypercalcemia despite corrective treatment (corrected calcemia = Calcium (mmol) + \[(40- albumin (g)) x 0.025\]).
• History of allogenic organ transplantation.
• Active or prior documented autoimmune disease or inflammatory disorders including but is not limited to inflammatory bowel disease (colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), sarcoidosis syndrome, myasthenia gravis, lupus erythematosus, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain Barré's syndrome, multiple sclerosis, vasculitis and glomerulonephritis. Patients with severe psoriasis (10% of your body's surface area) are not eligible.

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead

Study Sites (31)

Abbeville - CH

Abbeville, France

Location

Amiens - Clinique de l'Europe

Amiens, France

Location

Angers - CHU

Angers, France

Location

Besançon - CHU

Besançon, France

Location

Bordeaux - CHU

Bordeaux, France

Location

Boulogne - Ambroise Paré

Boulogne-Billancourt, France

Location

Caen - CHU Côte de Nacre

Caen, 14000, France

Location

Chambéry - CH

Chambéry, France

Location

Cholet - CH

Cholet, France

Location

Colmar - CH

Colmar, France

Location

Annemasse - CH

Contamine-sur-Arve, France

Location

Créteil - CHI

Créteil, France

Location

Dijon - CHU Bocage

Dijon, France

Location

Grenoble - CHU

Grenoble, France

Location

Le Mans - CHG

Le Mans, France

Location

Lyon - URCOT

Lyon, France

Location

Marseille - APHM

Marseille, France

Location

Marseille - Hôpital Européen

Marseille, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

Morlaix - CH

Morlaix, France

Location

Orléans - CHR

Orléans, France

Location

Paris - Bichat

Paris, France

Location

Paris - Hôpital Cochin

Paris, France

Location

Paris - Tenon

Paris, France

Location

Rennes - CHU

Rennes, France

Location

Nouvel Hôpital Civil - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Toulon - Sainte Anne HIA

Toulon, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

Tours - CHU

Tours, France

Location

Vandoeuvre-lès-Nancy - CRLCC

Vandœuvre-lès-Nancy, France

Location

Villefranche sur Saône - CH

Villefranche-sur-Saône, France

Location

MeSH Terms

Interventions

Carboplatin; Paclitaxel; durvalumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 12, 2023
• Study Start: November 17, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

FR (31)