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

NCT05994339 | Unknown Phase 2

• 1 other identifier: 20220808
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• overall survival(OS)

  the duration from treatment initiation to mortality resulting from any reason.

  2 years

Secondary Outcomes (2)

• progression-free survival (PFS)

  2 years

• Objective Response Rate (ORR):

  3 months

Study Arms (2)

Radiotherapy Combined with Almonertinib

EXPERIMENTAL

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.

Drug: Almonertinib

Radiotherapy Combined with Chemotherapy

ACTIVE COMPARATOR

Radiotherapy was administered using Intensity-Modulated Radiation Therapy (IMRT) technique, with a prescribed dose of 60 Gy in 30 fractions. Chemotherapy with paclitaxel at 135 mg/m2 and cisplatin at 70 mg/m2 was intravenously infused for two cycles during the 1st and 4th weeks. After the completion of radiotherapy, there was a rest period of 4 weeks, followed by continuation of the TP regimen for consolidation chemotherapy for 4 cycles.

Drug: Almonertinib

Interventions

Almonertinib DRUG

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.

Also known as: Intensity-Modulated Radiation Therapy(IMRT)

Radiotherapy Combined with Almonertinib; Radiotherapy Combined with Chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients initially diagnosed with lung cancer through imaging and pathological examination.
• Genetic testing confirms EGFR-sensitive mutations.
• Staging according to the international eighth edition of lung cancer TNM is between stage ⅢA to ⅢC.
• Age between 18 to 80 years old, without severe organ diseases such as heart, liver, kidney, etc.
• ⑤ General condition assessed with a performance status (PS) score of ≤2 points.

You may not qualify if:

• ① Patients with upper gastrointestinal physiological disorders, malabsorption syndrome, intolerance to oral medications, or peptic ulcers.
• Patients who have received previous radiotherapy or chemotherapy for lung conditions.
• Patients with concomitant chronic obstructive pulmonary disease, atelectasis, or other conditions that cause difficulties in lesion measurements.
• Patients with active pulmonary tuberculosis. ⑤ Patients with respiratory failure. ⑥ Patients with allergies to the investigational drugs used in this study. ⑦ Pregnant or lactating women. ⑧ Patients with any other diseases, neurological or metabolic disorders, physical examination or laboratory findings that may raise reasonable suspicions of certain diseases or conditions, which would either disqualify the use of the investigational drugs or place the subjects at high risk of treatment-related complications.

Sponsors & Collaborators

• Laibin People's Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms

Interventions

aumolertinib; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Oncology

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: September 1, 2023
• Primary Completion: August 8, 2025
• Study Completion: December 8, 2025
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share