Concurrent EGFR-TKIs and Thoracic Radiation Therapy in Active EGFR Mutation for 1st Line Treatment of Stage IV NSCLC

NCT02353741 | Terminated Phase 2

• 1 other identifier: XQonc-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This single-arm phase II study aims to study the efficacy of a possible first line treatment that combines epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKIs) with concurrent thoracic radiation therapy for stage IV non-small cell lung cancer (NSCLC) with active EGFR mutation, as well as assessing PFS, OS, tumor response, etc. to verify that this new combinational therapy can benefit short-term and long-term survival of the patients with advanced NSCLC.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 1-year rate of progression-free survival

  1-year rate of progression-free survival

  one year after treatment, followed

Secondary Outcomes (6)

• Overall survival (OS)

  From the time of study enrollment until the date of death

• Objective response rate

  up to three years

• Disease control rate

  up to three years

• patients quality of life

  up to three years

• Failure mode

  up to three years

Study Arms (1)

EGFR-TKIs combined with radiotherapy

EXPERIMENTAL

EGFR-TKIs combined with concurrent thoracic radiotherapy. Receive oral erlotinib 150mg per day with concurrent thoracic radiotherapy, within 2 weeks, pGTV54～60Gy/27～30f/5.5～6w.

Drug: EGFR-TKIs; Radiation: thoracic radiotherapy

Interventions

EGFR-TKIs DRUG

Beginning on day 2 of treatment, receive oral erlotinib 150mg per day.

EGFR-TKIs combined with radiotherapy

thoracic radiotherapy RADIATION

From the beginning of EGFR-TKIs, within 2 weeks, receive concurrent thoracic radiotherapy, pGTV54～60Gy/27～30f/5.5～6w.

Also known as: thoracic radiation

EGFR-TKIs combined with radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status≤2；
• Cytologically or pathologically confirmed stage IV NSCLC ( controlled pleural effusion will be eligible) with active EGFR mutation;
• Estimated survival time more than 3 months;
• Age older than 18 years and under 75 years;
• Adequate bone marrow, hepatic, and renal function;AST and ALT≤2.5 times the highest reference value when not associated with hepatic metastases, or ≤5 times when hepatic metastases occur;
• Without history of therapy for primary and metastatic disease;
• With pleural effusion but can be controlled;
• Asymptomatic bone metastases without treatment;
• Based on fusion images of 4DCT MIP sketch tumors and lymph nodes, and limit the mean lung dose: V20≤25%，V30≤18%，MLD≤14Gy，V5≤60%;
• M1a or M1b for metastases, and the number of the distant lesions ≤10；
• Voluntary to participate in this clinical trial and sign the consent form.

You may not qualify if:

• Patients with serious functional damage of important organs;
• Patients diagnosed adequately with other malignant tumors;
• Pregnant or lactating women;
• Patients in an active period of acute or chronic infectious diseases;
• Patients who are allergic to any drugs or people with allergies;
• With brain metastases;
• With bone metastases needing radiotherapy;
• Patients who participate in other clinical trials concurrently;
• Uncontrolled pleural effusion which may intervene the radiotherapy to primary tumor in lung;
• The number of the distant lesions\>10；
• Patients who are considered not eligible for the trial after evaluation by investigator.

Sponsors & Collaborators

• Xinqiao Hospital of Chongqing: lead

Study Sites (1)

Xinqiao Hospital of Chongqing

Chongqing, 400000, China

Location

Related Publications (1)

• Zheng L, Wang Y, Xu Z, Yang Q, Zhu G, Liao XY, Chen X, Zhu B, Duan Y, Sun J. Concurrent EGFR-TKI and Thoracic Radiotherapy as First-Line Treatment for Stage IV Non-Small Cell Lung Cancer Harboring EGFR Active Mutations. Oncologist. 2019 Aug;24(8):1031-e612. doi: 10.1634/theoncologist.2019-0285. Epub 2019 Apr 30.

  PMID: 31040256 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The deputy director of oncology department of Xinqiao Hospital

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 3, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

CN (1)