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A prospective, multicentre study to see the safety of Osimertinib in Indian adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer.

A prospective, multicenter, Phase-IV clinical trial to assess safety of TAGRISSO (Osimertinib) in Indian adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/015941
Enrollment
60
Registered
2018-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive nonsmall cell lung cancer (NSCLC) Health Condition 2: C341- Malignant neoplasm of upper lobe,bronchus or lung

Interventions

None listed

Sponsors

AstraZeneca Pharma India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patient of either sex and >=18 years of age 2 Patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an appropriate test, who have progressed on or after EGFR TKI therapy by an independent clinical judgment of treating physician based on locally approved prescribing information 3 Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: Patient with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug. 2 Pregnant and/or lactating women 3 Patients participating in any current or future interventional trial will not be enrolled in the current study

Design outcomes

Primary

MeasureTime frame
Number frequency and proportion of patients with adverse events (AEs) serious adverse events (SAEs) and AEs of special interest (AESI) including interstitial lung disease or pneumonitis like events and on study deathsTimepoint: NA

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactAmit Kumar

AstraZeneca Pharma India Ltd

mangesh.sheshraokamle@astrazeneca.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026