Immunotherapy in Patient With Poor General Condition

NCT04108026 | Completed Phase 2 DMC

• 1 other identifier: IFCT-1802
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 20

Brief Summary

Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC). The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy. The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients. For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS \>3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

Conditions

Non-small Cell Lung Cancer Stage IV

Keywords

IFCT; Savimmune; Non small cell Lung Cancer; PS; Poor General condition; Lung Cancer; Durvalumab

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing Grade 3-5 Treatment Related Adverse Event at 8 weeks of durvalumab

  8 weeks

Secondary Outcomes (9)

• Incidence, type and severity of adverse event

  From time of informed consent through treatment period (24 months) or up to 100 days post last dose of study treatment

• Disease Control Rate

  8 weeks

• Objective Response Rate according to BICR (Blinded Independent Central Review) and investigators

  8 weeks (confirmed at 16 weeks)

• Progression free survival

  6 and 12 months

• Overall survival

  6 and 12 months

Study Arms (1)

Immunotherapy

EXPERIMENTAL

Durvalumab 1500 mg every 4 weeks until the progression of disease, discontinuation due to toxicity or withdrawal of consent, for a maximum duration of 2 years.

Drug: Durvalumab

Interventions

Durvalumab DRUG

1500 mg IV every 4 weeks

Immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have signed and dated an IEC (Independent Ethic Committee) 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.
• Histologically or cytologically-proven NSCLC (squamous or non-squamous). If the diagnosis is cytologically-proven, sufficient material is necessary with at least 100 tumor cells evaluated for PD-L1 IHC (Immunohistochemistry).
• PD-L1 expression ≥25% of tumor cells as assessed by the local pathology laboratory using protocols validated.
• Available tumor samples for centralized PD-L1 immunohistochemistry analysis.
• No EGFR (Epidermal Growth Factor Receptor) mutation and no ALK(Anaplasic Lymphoma Kinase) gene rearrangement.
• Stage IV (8th classification TNM) M1a or M1b or M1c.
• ECOG (Eastern Cooperative Oncology Group) PS = 2 or 3 despite optimal symptomatic treatment.
• Body weight \>30kg
• No prior systemic anticancer therapy (chemotherapy, immunotherapy including durvalumab, or EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease. Neoadjuvant or adjuvant chemotherapy is not considered as chemotherapy for advanced or metastatic disease.
• Limited field of radiation for palliation within 2 weeks of the first dose of durvalumab is allowed, provided the lung is not in the radiation field and irradiated lesion(s) cannot be used as target lesions.
• Age 18-75 years.
• Measurable tumor disease by CT per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Life expectancy \> 8 weeks according to the investigator opinion.
• Adequate biological functions:

You may not qualify if:

• Pure or combined SCLC.
• Known HER2 (Human Epidermal Growth Factor Receptor), B-Raf, activating tumor mutations, or exon 14 c-MET splice mutations (mesenchymal-epithelial transition), or known ROS1 gene rearrangement.
• Asymptomatic or symptomatic brain metastasis.
• Carcinomatous meningitis.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Patients without active disease in the last 5 years may be included but only after consultation with IFCT
• Patients with celiac disease controlled by diet alone
• Immunosuppressive treatment including systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 15 days before enrollment. Inhaled, nasal or topic corticosteroids are allowed.
• History of allogenic organ transplantation.
• Stage 4 (very severe, FEV1 (forced expiratory volume at one second) \<30% predicted) chronic obstructive pulmonary disease (COPD) according to GOLD classification.
• NYHA (New York Heart Association) class 4 chronic heart failure
• Pre-existing interstitial lung.

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead

Study Sites (20)

Besançon - CHU

Besançon, France

Location

Hôpital Ambroise Paré - Pneumologie

Boulogne, France

Location

Caen - CHU Côte de Nacre

Caen, 14000, France

Location

CH

Colmar, France

Location

CHRU Grenoble

Grenoble, France

Location

Centre Hospitalier - Pneumologie

Le Mans, 72000, France

Location

CHRU de Lille

Lille, France

Location

AP-HM Hopital Nord

Marseille, France

Location

Montpellier - CHRU

Montpellier, 34295, France

Location

GRH Mulhouse Sud-Alsace

Mulhouse, France

Location

Nancy - Institut de Cancérologie de Lorraine

Nancy, France

Location

Nantes - ICO Site René Gauducheau

Nantes, 44805, France

Location

CHR d'Orléans La Source

Orléans, France

Location

AP-HP Hopital Tenon - Pneumologie

Paris, 75020, France

Location

Paris - APHP Bichat

Paris, France

Location

Paris - Curie

Paris, France

Location

Lyon - URCOT

Pierre-Bénite, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Toulouse - Pneumologie

Toulouse, France

Location

CHU Tours - Pneumologie

Tours, France

Location

Related Links

• IFCT website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Valérie GOUNANT

  AP-HP Hôpital Bichat-Claude Bernard

  STUDY CHAIR

• Michael DURUISSEAUX

  Hospices Civils de Lyon - Hôpital Louis Pradel

  STUDY CHAIR

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: September 24, 2019
• First Posted: September 27, 2019
• Study Start: October 14, 2020
• Primary Completion: November 30, 2023
• Study Completion: September 26, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (20)