Gefitinib With or Without Chemotherapy in Brain Metastases From Non-small Cell Lung Cancer

NCT ID: NCT01951469

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2022-12-31

Brief Summary

This is a multi-center phase III randomized controlled study to assess the efficacy of Gefitinib alone and Gefitinib combination with Pemetrexed/platinum on patients with brain metastasis from non-small cell lung cancer(NSCLC) harboring EGFR mutation type by intracranial PFS(iPFS),also PFS ,DCR and OS.The side effect is evaluated as well.

Conditions

Non-small Cell Lung Cancer; Brain Metastases; EGFR Mutation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gefitinib and Pemetrexed/platinum

Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) chemotherapy or Pemetrexed (D1)+nedaplatin (D1) chemotherapy, every 28 days

Group Type: EXPERIMENTAL

Gefitinib and Pemetrexed/platinum

Intervention Type: DRUG

Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) or Pemetrexed (D1) + nedaplatin (D1) chemotherapy, every 28 days

Gefitinib mono-therapy

Gefitinib 250mg is Taken Orally everyday

Group Type: ACTIVE_COMPARATOR

Gefitinib mono-therapy

Intervention Type: DRUG

Gefitinib 250mg is Taken Orally everyday

Interventions

Gefitinib and Pemetrexed/platinum

Gefitinib 250mg is Taken Orally on day 1-28,combined Pemetrexed (D1)+cisplatin (D1-3) or Pemetrexed (D1) + nedaplatin (D1) chemotherapy, every 28 days

Intervention Type: DRUG

Gefitinib mono-therapy

Gefitinib 250mg is Taken Orally everyday

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology

2. Patients who had never received therapy (including chemotherapy,WBRT,EGFR-TKI and EGFR monoclonal antibody) after diagnosed brain metastases

3. Patients had at least three metastatic lesions in brain, or patients with 1-2 intracranial lesions who were not suitable for brain radiotherapy, or patients with 1-2 intracranial lesions who refused brain radiotherapy, at least one intracranial lesion with the longest diameter of >5 mm

4. Adult patients (≥ 18 years and ≤75 years). ECOG Performance Status 0 or 1 Life expectancy of at least 12 weeks.,Haemoglobin ³ 10.0 g/dl, Absolute neutrophil count (ANC) ³1.5 x 109/L, platelets ³ 100 x 109/L. Total bilirubin £ 1.5 x upper limit of normal (ULN). ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases. Creatinine clearance ³ 60ml/min (calculated according to Cockcroft-gault formula).

5. Patients should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.

6. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Exclusion Criteria

1. Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.

2. Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.

3. Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.

4. Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .

5. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).

6. Any significant ophthalmologic abnormality ,especially severe dry eye syndrome ,keratoconjunctivitis sicca,Sjogren syndrome,severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.

7. Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.

8. The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wu Jieping Medical Foundation

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li-kun Chen

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University of Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

li-kun Chen, MD

Role: CONTACT

chenlk@sysucc.org.cn

13798019964

Xue Hou

Role: CONTACT

houxue@sysucc.org.cn

13570569436

Facility Contacts

li-kun Chen, doctor

Role: primary

chenlk@sysucc.org.cn

13798019964

References

Hou X, Li M, Wu G, Feng W, Su J, Jiang H, Jiang G, Chen J, Zhang B, You Z, Liu Q, Chen L. Gefitinib Plus Chemotherapy vs Gefitinib Alone in Untreated EGFR-Mutant Non-Small Cell Lung Cancer in Patients With Brain Metastases: The GAP BRAIN Open-Label, Randomized, Multicenter, Phase 3 Study. JAMA Netw Open. 2023 Feb 1;6(2):e2255050. doi: 10.1001/jamanetworkopen.2022.55050.

Reference Type: DERIVED

PMID: 36753281 (View on PubMed)

Other Identifiers

NSCLC brain metastasis 01

Identifier Type: -

Identifier Source: org_study_id