Study to Access Safety of Durvalumab in Indian Adult Patients With Locally Advanced NSCLC

NCT04416633 | Completed Phase 4 Results

• 1 other identifier: D133HC00003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

Brief Summary

A prospective, multicenter, Phase-IV clinical trial to assess safety of Durvalumab in Indian adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC)

Conditions

Unresectable Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

• Number and Proportion of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)

  The number and proportion of participants who experienced AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.

  Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])

• Number of Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESI)

  The number of events of AEs, SAEs, and AESIs, including interstitial lung disease/pneumonitis-like events and on-study deaths are presented.

  Evaluation Phase (Day 1 to 141) to Follow-up Phase (90 days after End of Evaluation Visit [Day 141])

Study Arms (1)

Durvalumab

OTHER

Single arm, Durvalumab , IV

Drug: Durvalumab

Interventions

Durvalumab DRUG

500-mg/120-mg IV

Durvalumab

Eligibility Criteria

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

You may qualify if:

• Provision of signed, written and dated informed consent prior to any study specific Procedures
• Male or female aged 18 years or older
• As per local prescribing information and in view of positive benefit-risk assessment, patient prescribed Durvalumab treatment as per independent clinical judgment of treating physician for either

You may not qualify if:

• Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
• Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug, 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. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
• Prior exposure to any anti-PD-1 or anti-PD-L1 antibody including durvalumab.
• For NSCLC cohort only:
• Mixed small cell and non-small cell lung cancer histology
• Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy.
• Patients with ≥Grade 2 pneumonitis from prior chemoradiation therapy
• Active or prior documented autoimmune disease within the past 2 years, inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), primary immunodeficiency, organ transplant that requires therapeutic immunosuppression, hypersensitivity to study drug or any excipient, leptomeningeal carcinomatosis, tuberculosis.
• NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
• Female patients 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 the study drug or interpretation of patient safety or study results.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Bangalore, 560017, India

Location

Research Site

Bangalore, 560022, India

Location

Research Site

Delhi, 110029, India

Location

Research Site

Delhi, 110085, India

Location

Research Site

Faridabad, 121001, India

Location

Research Site

Gūrgaon, 122001, India

Location

Research Site

Kolkata, 700160, India

Location

Research Site

Mohali, 160055, India

Location

Research Site

Mumbai, 400012, India

Location

Research Site

Mumbai, 400053, India

Location

Research Site

Mumbai, 400056, India

Location

Research Site

New Delhi, 110005, India

Location

Related Links

• D133HC00003\_CSP\_Redacted
• D133HC00003\_SAP\_Redacted
• D133HC00003\_CSR Synopsis\_Redacted

MeSH Terms

Interventions

durvalumab

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: November 30, 2021
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

IN (12)