Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer

NCT03030131 | Terminated Phase 2

• 1 other identifier: IFCT-1601
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 31

Brief Summary

Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA) NSCLC is curative surgery. Although patients treated with curative surgery have a better prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative chemotherapy versus no chemotherapy have shown a significant overall survival benefit from postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA. Likewise other randomized trials have demonstrated preoperative chemotherapy improves survival and recently the analyses also based on individual patients data of 15 randomized trials showed a significant benefit of preoperative chemotherapy on survival with the same survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become accepted in many countries. Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an attractive therapeutic option in the early stage NSCLC, which may reactivate host immune responses and enable longterm tumor control.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

IFCT; neodjuvant; immune therapy; Non small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Surgical resection R0

  Patient percentage of surgical resection R0 after a maximum of 3 cycles of immune therapy

  2 months

Secondary Outcomes (9)

• Response Rate (recist 1.1)

  After 28 days (3 cycles of immune therapy maximum)

• Metabolic response rate on TEP-FDG

  After 28 days (3 cycles of immune therapy maximum)

• Delay between surgery and start of treatment

  After 28 days (3 cycles of immune therapy maximum)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 month

• Disease-Free Survival (DFS)

  1 year

Study Arms (1)

Durvalumab

EXPERIMENTAL

durvalumab 750 mg IV J1, J15, J29

Drug: Durvalumab

Interventions

Durvalumab DRUG

durvalumab 750 mg IV Day1, 15, 29

Also known as: MEDI4736

Durvalumab

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.
• Pre-operative (neo-adjuvant) platinum based or other chemotherapy except the treatment of the protocol is not permissible. Pre-operative radiation therapy is not permissible
• The patient must have an ECOG performance status of 0, 1.
• Haemoglobin ≥ 9,0 g/dL Absolute neutrophil count \> 1.5 x 109/L or \> 1,500/µl Platelets \> 100 x 109/L or \> 100,000/µl
• \* excluding Gilbert's syndrome
• Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by Cockcroft Formula:
• Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23 x (140-age) x weight in kg serum creatinine in μmol/L
• Other investigations detailed in Section 6 must have been performed within the timelines indicated.
• Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients included on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• Age of at least 18 years.
• Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥60 years old and no menses for ≥ 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.
• Females of childbearing potential who are sexually active with a nonsterilized male partner or men who are sexually active with women of childbearing potential must use a highly effective method of contraception prior the first dose of investigational product, and must agree to continue using such precautions for 4 months after the final dose of investigational product. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.

You may not qualify if:

• Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for \> 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
• A combination of small cell and non-small cell lung cancer or pulmonary carcinoid tumour.
• \* NOTE: Intranasal/inhaled corticosteroids or systemic steroids that do not to exceed 10 mg/day of prednisone or equivalent dose of an alternative corticosteroid are permissible.
• History of hypersensitivity to durvalumab or any excipient.
• Concurrent treatment with other investigational drugs or anti-cancer therapy.
• Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:
• known prior history of tuberculosis;
• known acute hepatitis B or C by serological evaluation;
• known Human immunodeficiency virus infection.
• Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
• Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
• Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
• Known history of previous clinical diagnosis of tuberculosis
• Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
• Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead

Study Sites (31)

Amiens - Clinique de l'Europe

Amiens, France

Location

Argenteuil - CH

Argenteuil, France

Location

Bayonne - CH

Bayonne, France

Location

Bordeaux - Institut Bergonié

Bordeaux, France

Location

Caen - CHU

Caen, France

Location

Caen - CRLCC

Caen, France

Location

Chauny - CH

Chauny, France

Location

Clermont-Ferrand - CHU

Clermont-Ferrand, France

Location

Cornebarrieu - Clinique des Cèdres

Cornebarrieu, France

Location

Grenoble - CHU

Grenoble, France

Location

Le Mans - CHG

Le Mans, France

Location

Limoges - CHU

Limoges, France

Location

Mantes La Jolie - CH

Mantes-la-Jolie, France

Location

AP-HM Hopital Nord

Marseille, France

Location

Marseille - Hôpital Européen

Marseille, France

Location

Metz - Hôpital Robert Schuman

Metz, France

Location

Mulhouse - CH

Mulhouse, 68000, France

Location

Nancy - Polyclinique Gentilly

Nancy, France

Location

Nantes - CRLCC

Nantes, France

Location

Paris - Hopital Tenon

Paris, 75020, France

Location

Paris - HEGP

Paris, France

Location

Paris - Hôpital Cochin

Paris, France

Location

Paris - Montsouris

Paris, France

Location

Paris - Saint Joseph

Paris, France

Location

Paris Bichat

Paris, France

Location

Pau - CHG

Pau, France

Location

Centre René Huguenin

Saint-Cloud, France

Location

Institut de Cancérologie de l'Ouest - site René Gauducheau

Saint-Herblain, France

Location

Saint-Quentin - CH

Saint-Quentin, France

Location

Strasbourg - NHC

Strasbourg, 63000, France

Location

Toulouse - CHU Larrey

Toulouse, France

Location

Related Publications (1)

• Wislez M, Mazieres J, Lavole A, Zalcman G, Carre O, Egenod T, Caliandro R, Dubos-Arvis C, Jeannin G, Molinier O, Massiani MA, Langlais A, Morin F, Le Pimpec Barthes F, Brouchet L, Assouad J, Milleron B, Damotte D, Antoine M, Westeel V. Neoadjuvant durvalumab for resectable non-small-cell lung cancer (NSCLC): results from a multicenter study (IFCT-1601 IONESCO). J Immunother Cancer. 2022 Oct;10(10):e005636. doi: 10.1136/jitc-2022-005636.

  PMID: 36270733 DERIVED

Related Links

• Site web

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

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

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: January 12, 2017
• First Posted: January 24, 2017
• Study Start: January 12, 2017
• Primary Completion: August 28, 2019
• Study Completion: August 28, 2019
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

FR (31)