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

NCT01951469 | Unknown Phase 3 DMC

• 1 other identifier: NSCLC brain metastasis 01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• iPFS(intracranial progression free survival

  defined as time from randomization to intracranial progressive disease or death.

  2 years

Secondary Outcomes (5)

• ORR

  2 years

• intracranial objective response rate (iORR)

  2 years

• PFS(Progression Free Survival)

  2 years

• OS(Overall Survival)

  3 years

• adverse events

  3 years

Study Arms (2)

Gefitinib and Pemetrexed/platinum

EXPERIMENTAL

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

Drug: Gefitinib and Pemetrexed/platinum

Gefitinib mono-therapy

ACTIVE COMPARATOR

Gefitinib 250mg is Taken Orally everyday

Drug: Gefitinib mono-therapy

Interventions

Gefitinib and Pemetrexed/platinum 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 and Pemetrexed/platinum

Gefitinib mono-therapy DRUG

Gefitinib 250mg is Taken Orally everyday

Gefitinib mono-therapy

Eligibility Criteria

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

You may qualify if:

• Patient who was confirmed stage IV NSCLC with EGFR activating mutation and brain metastases by pathologic histology or cytology
• Patients who had never received therapy (including chemotherapy,WBRT,EGFR-TKI and EGFR monoclonal antibody) after diagnosed brain metastases
• 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
• 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).
• Patients should be contraceptive during the period of the trial until 8 weeks after the last administration of icotinib.
• Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

You may not qualify if:

• Patient was received irradiation of brain. Patient with meningeal metastases were confirmed by MRI or cytology test of cerebrospinal fluid.
• Patient is received the treatment of Phenytoin, carbamazepine, rifampicin, phenobarbital, or St. John's Wort.
• Patient was received EGFR Tyrosine Kinase Inhibitor or EGFR monoclonal antibody.
• Interstitial pneumonia.Pericardial effusion, pleural effusion is uncontrolled .
• 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).
• 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.
• Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease.
• The symptoms of increased intracranial pressure are uncontrolled after dehydration and cortisone treatment

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Wu Jieping Medical Foundation: collaborator

Study Sites (1)

Sun Yat-sen University of Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36753281 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Brain Neoplasms

Interventions

Gefitinib; Pemetrexed; Platinum

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

li-kun Chen, MD

CONTACT

13798019964; chenlk@sysucc.org.cn

Xue Hou

CONTACT

13570569436; houxue@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 26, 2013
• Study Start: January 1, 2016
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Locations

CN (1)