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Radiotherapy Combined With Almonertinib for Stage III EGFR-Mutated Lung Cancer

NCT05994339 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-29

No results posted yet for this study

Summary

Study Object: Stage III lung cancer with epidermal growth factor receptor (EGFR) sensitive mutation.

Study Method: The study subjects will be randomly assigned to the intervention group and the control group. The intervention group will receive radiotherapy combined with erlotinib treatment, while the control group will receive concurrent radiotherapy combined with chemotherapy. The differences in short-term efficacy, long-term efficacy, and incidence of adverse reactions between the two groups will be observed.

Observation Indicators: Short-term efficacy indicators: Complete remission (CR) rate, partial remission (PR) rate, and objective response rate (ORR). Long-term efficacy indicators: Overall survival (OS) and progression-free survival (PFS). Adverse reaction indicators: Incidence of lung toxicity, hematological toxicity, and gastrointestinal reactions.

Conditions

  • Lung Cancer Stage III

Interventions

DRUG

Almonertinib

Radiotherapy was administered using Intensity-Modulated Radiation Therapy (IMRT) technique, with a prescribed dose of 60 Gy in 30 fractions. Almonertinib was orally administered at 110 mg per day, starting from the first day of radiotherapy and continued for 42 days until the completion of radiotherapy, followed by continuous medication until disease progression.

Sponsors & Collaborators

  • Laibin People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-08-08
Completion
2025-12-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05994339 on ClinicalTrials.gov