Erlotinib Monotherapy Versus Docetaxel and Cisplatin as Neoadjuvant Therapy in Patients of stageIIIA Lung ca

Phase 2

• Conditions: Non-small Cell Lung Cancer(NSCLC)
• Interventions: Drug: erlotinib; Drug: docetaxel

• Registration Number: NCT02036359
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To compare clinical response (complete response and partial response) by RECIST) rates by RECIST between erlotinib monotherapy and docetaxel plus cisplatin chemotherapy

Detailed Description

an open-label, multi-centre, randomized, phase II study evaluating efficacy of erlotinib monotherapy vs. docetaxel plus cisplatin chemotherapy.

Patients with histological documented stage IIIA lung adenocarcinoma. The tumor specimens were examined for EGFR gene mutation (Exon 18-21).

Those with exon 19 deletion and L858R, G719X, L861Q mutation were randomized as erlotinib monotherapy or docetaxel plus cisplatin chemotherapy.

The randomization will be stratified by center

Study treatment Patients will receive treatment for 9 weeks unless disease progression, unacceptable toxicity or death.

Erlotinib arm:

Patients in erlotinib arm will take erlotinib 150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.

Chemotherapy arm:

Patients in chemotherapy arm will then receive 3 cycles (9 weeks) of chemotherapy with docetaxel 35mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 8.

Treatment failure will include patients who fail to complete 3 cycles (9 weeks) of study treatments due to disease progression or unacceptable toxicity.

Patients with no disease progression after terminating study treatment will undergo surgical resection and be followed until disease progression is noted, or study end. Survival will be recorded and analyzed.

If progressive disease or unacceptable toxicity occurs during study treatments, patients will be treated at discretion of investigator according to local protocol.

Please note:

• If it is judged by the investigator to be in the best interest of the patient, patients discontinuing study treatment may receive second-line treatment.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-09-24
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-14
• Last Update Submitted: 2014-01-14
• Study First Posted: 2014-01-15
• Last Update Posted: 2014-01-15
• Primary Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• • Age ≥ 18 years, male or female

  • Able to comply with the protocol
  • Histologically documented stage IIIA lung adenocarcinoma
  • ECOG performance status 0-2
  • If the patient has the use coumarin (coumarin) (also to be called coumadin or warfarin), the patient applies drugs previous 7 days at the experiment to stop the medicine, and changes to other for to use the medicine.
  • Life expectancy > 12 weeks
  • Tumor specimen with EGFR gene mutation of exon 19 deletion and L858R, G719X, L861Q mutation
  • Adequate hematological function: ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, Hb ≥ 9 g/dL
  • Data of INR and PTT should be available in patients taking anticoagulants concomitantly, with INR ≤ 1.5 and PTT ≤ 1.5 times the upper limit of normal (x ULN ) within 7 days prior to starting study treatment
  • Adequate liver function: serum bilirubin ≤ 1.5 x ULN; transaminases ≤ 2.5 x ULN
  • Adequate renal function: 24-hour urine creatinine clearance or creatinine clearance measured and calculated according to the formula of Cockroft and Gault ≥ 60ml/min
  • Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women
  • Written informed consent.
  • Patients are willing to complete FACT-L, ED-5Q, or pharmacoeconomic questionnaires

Exclusion Criteria

• • Prior chemotherapy or treatment with another systemic anti-cancer agent (for example monoclonal antibody, tyrosine kinase inhibitor)

  • Mixed adenocarcinoma and other histological type of lung cancer
  • Unable to take oral medicine
  • Pregnant or lactating women
  • Fertile men or women of childbearing potential not using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
  • Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, DCIS treated surgically with curative intent
  • Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to starting study treatment
  • Known hypersensitivity to any of the study drugs
  • Concurrent cancer treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erlotinib	erlotinib	Patients in erlotinib arm will take erlotinib 150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.
Chemotherapy	docetaxel	Patients in chemotherapy arm will then receive 3 cycles (9 weeks) of chemotherapy with docetaxel 35mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 8. Treatment failure will include patients who fail to complete 3 cycles (9 weeks) of study treatments due to disease progression or unacceptable toxicity. Patients with no disease progression after terminating study treatment will undergo surgical resection and be followed until disease progression is noted, or study end. Survival will be recorded and analyzed. If progressive disease or unacceptable toxicity occurs during study treatments, patients will be treated at discretion of investigator according to local protocol.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Event	Within 28 days of last study dose

Trial Locations

Locations (1)

Department of Oncology, National Taiwan University Hospital; 🇨🇳 Taipei,, Taiwan