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NCT Number: NCT06709859

Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC

This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shandong Public Health Clinical Center

Jinan, Shangdong, 250000, China

Location status: Recruiting

Location contact

hua zhang

CONTACT

[email protected]

0531-83347512

About this study

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator.
  • Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation
  • ECOG Performance Status of 0-1
  • At least one measurable lesion according to RECIST 1.1
  • Adequate organ and marrow function

Exclusion criteria

  • Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
  • The presence of malignant pleural effusion
  • Prior systemic anti-cancer therapy for non-small cell lung cancer
  • Prior local radiotherapy for NSCLC
  • Patients with uncontrolled gastrointestinal diseases that may affect the absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment

Treatment and study plan

Afatinib plus chemotherapy as conversion treatment

Drug

Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.

Primary outcomes

  1. The rate of NSCLC converting to resectable tumors

    Time frame: Up to 12 weeks

    The proportion of unresectable NSCLC patients who are converted to being suitable for surgery after 3-4 cycles afatinib plus chemotherapy.

Secondary outcomes

  1. R0 resection rate

    Time frame: immediately after the surgery

    The proportion of R0 resection in patients who receive surgery

  2. Major pathologic response (MPR) Rate

    Time frame: Up to 12 weeks

    The proportion of patients who achieve MRP among those receiving surgery

  3. Pathologic complete response (pCR) Rate

    Time frame: Up to 12 weeks

    The proportion of patients who achieve pCR among those receiving surgery

  4. Tumor downstaging rate

    Time frame: Up to 12 weeks

    The proportion of patients who reach the successful downstaging criteria for NSCLC

  5. Objective response rate (ORR)

    Time frame: Up to five years

    The proportion of patients who have a complete response (CR) or partial response (PR).

  6. Disease control rate (DCR)

    Time frame: Up to five years

    The proportion of patients who have a best overall response of CR, PR, or stable disease (SD).

  7. Event-free survival (EFS)

    Time frame: Up to five years

    The length of time after initial administration the patient remains free of recurrence/progression or death, whatever the cause.

  8. The 2-year progression-free survival (PFS) rate

    Time frame: Up to two years

    The proportion of patients who are event-free.

  9. Overall Survival (OS)

    Time frame: Up to five years

    The length of time after initial administration the patient remains alive

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Zhang, PhD

CONTACT

[email protected]

0531-83347512

Sponsors and collaborators

Lead sponsor

Shandong Public Health Clinical Center

Other Gov

Registry information

Official study title

A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 29, 2024
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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