An Open-label, Randomized Phase II Study to Evaluate the Efficacy of AUY922 vs Pemetrexed or Docetaxel in NSCLC Patients With EGFR Mutations
Condition: Advanced Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: AUY922; Docetaxel; Pemetrexed
Intervention description: AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.; Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity; Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity
Intervention MeSH terms: Docetaxel; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-small cell lung carcinoma (NSCLC); treatment of lung cancer after first metastasis; lung cancer; lung adenocarcinoma; Squamous cell lung carcinoma; Large-cell lung carcinoma; Non small cell lung carcinoma; Non small cell lung cancer; Non-small cell lung cancer; NSCLC; Large cell lung carcinoma; Large cell lung cancer; HSP90; AUY922; Pemetrexed; Docetaxel; EGFR TKI; EGFR mutations

Summary:

      The purpose of this study was to determine if AUY922 had superior efficacy when compared to
      chemotherapy agents docetaxel or pemetrexed in patients whose tumor had EGFR mutations.

      The primary purpose of this study was to compare the efficacy of AUY922, when administered
      i.v. on a once-weekly schedule at 70 mg/m2, versus docetaxel or pemetrexed in adult patients
      with advanced NSCLC, whose tumors harbored EGFR activating mutations, and had developed
      resistance to EGFR TKI.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with histologically or cytologically documented, locally advanced (stage IIIB
             who are not amenable to combined modality treatment) or recurrent or metastatic (Stage
             IV) non-small cell lung cancer.

          2. Patients must have EGFR gene mutation in their tumors. This can be source - documented
             by one of the following:

             • Provide a pathology report that indicates the patient's tumor had EGFR activating
             mutation in the past.

             Or:

             • Perform testing (local or central) in an archival tumor or a fresh baseline biopsy
             tumor tissue to show the presence of EGFR activating mutation.

          3. Patients must have documented clinical benefit (CR, PR, or patients with SD for 6
             months or greater) on prior EGFR TKI (e.g. erlotinib or gefitinib) followed by
             documented progression according to RECIST.

          4. Patients must have received prior platinum containing treatment.

          5. WHO performance status of 0-1

        Exclusion Criteria:

          1. Patients who have received more than two prior lines of antineoplastic therapy for
             advanced disease. Chemotherapy administered as neoadjuvant or adjuvant treatment more
             than six months prior to study enrollment is not considered a prior line of therapy
             for purposes of this study.

          2. Evidence of spinal cord compression or current evidence of CNS metastases. Screening
             CT/MRI of the brain is mandatory. Note: Patients who have been treated for CNS
             metastases by radiation or gamma knife surgery, who been stable for at least 2 months
             and have discontinued high dose corticosteroids will be eligible for protocol
             participation

          3. Prior treatment with an HSP90 inhibitor