A study to evaluate efficacy of thrice weekly osimertinib combined with chemotherapy in patients with EGFR Positive advanced Non small cell lung carcinoma

Phase II trial of safety and efficacy after thrice weekly Osimertinib combined with standard of care chemotherapy in patients with Epidermal Growth Factor Receptor (EGFR) Positive advanced Non-small cell lung carcinoma (NSCLC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062382

Enrollment

Registered

2024-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung

Interventions

Intervention1: Thrice weekly Osimertinib with Carboplatin + Pemetrexed: Patients will be given Tab. Osimertinib 80mg once daily on alternate days (Monday, Wednesday and Friday) and intravenous Carbopl

Eligibility

Inclusion criteria

Inclusion criteria: 1) Metastatic non small cell carcinoma 2) EGFR mutation positive lung cancer 3) Performance status 0-1

Exclusion criteria

Exclusion criteria: 1) Previously treated lung cancer 2) Unstable CNS metastasis 3) Concurrent other malignancies 4) Major cardiac condition 5) Inadequate bone marrow reserve 6) Pregnancy

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) at 9weeks after initiation of the study regimenTimepoint: Objective response rate (ORR) at 9weeks after initiation of the study regimen	—

Secondary

Measure	Time frame
1) Pharmacokinetics 2) Time to Progression 3) Adverse events with study regimenTimepoint: 1) Pharmacokinetics of thrice weekly osimertinib will be analyzed by measuring osimertinib blood levels drawn at 6 weeks & 9 weeks after initiation of study regimen. 2) Time to progression: Tumor assessments of chest & abdomen will be performed at screening & after 9 weeks from initiation of treatment & then every 12 weeks until the occurrence of disease progression. 3) Adverse events with study regimen will be recorded at 3weekly intervals.	—

Measure

Time frame

1) Pharmacokinetics 2) Time to Progression 3) Adverse events with study regimenTimepoint: 1) Pharmacokinetics of thrice weekly osimertinib will be analyzed by measuring osimertinib blood levels drawn at 6 weeks & 9 weeks after initiation of study regimen. 2) Time to progression: Tumor assessments of chest & abdomen will be performed at screening & after 9 weeks from initiation of treatment & then every 12 weeks until the occurrence of disease progression. 3) Adverse events with study regimen will be recorded at 3weekly intervals.

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Countries

India

Contacts

Public ContactAnil Kumar Subbarao

Christian Medical College

ashishsingh@cmcvellore.ac.in6383442826

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026