Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
A Phase I-II, Multicenter, Open-label Trial of Co-administered CHR-2797 and Erlotinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
This is an open-label, multicenter, multiple-dose, Phase I-II study of CHR-2797
co-administered with erlotinib in patients with histologically or pathologically confirmed
Stage IIIB (with pleural effusion), Stage IV, or recurrent metastatic NSCLC. Throughout this
protocol, "study medication" includes both CHR-2797 and erlotinib.
This study will involve 2 distinct study phases. Study Phase A will assess safety and
determine the MTD of the combination of CHR-2797 and erlotinib. In addition, PK profiles for
the combination of CHR-2797 and erlotinib will be evaluated. In Study Phase B, the dose
chosen based on the maximum tolerated dose established in Study Phase A will be administered
in a single-arm treatment design in order to evaluate the efficacy of co-administration of
CHR-2797 and erlotinib.
Study Phase A:
Maximum tolerated dose will be determined during Cycle 1. Tumor assessments will be made
after Cycle 2 (56 days), although it is not mandatory for Phase A patients to have
measurable disease. Patients who have satisfactory outcomes after Cycle 2 may continue
treatment for up to a year with erlotinib 150 mg/day, and the dose of CHR-2797 they received
in Study Phase A.
Study Phase B:
Patients will be treated with the dose of CHR-2797 selected in Study Phase A and 150mg/day
erlotinib. Patients will receive 2 cycles of treatment (56 days) before efficacy assessment.
Patients who have complete response, partial response, or stable disease are eligible to
continue the study for up to a year until disease progression or unacceptable toxicity. If a
patient has complete response, partial response, or stable disease at the end of the 1-year
study period and the Investigator believes that continuation treatment would be beneficial,
the patient may continue to be treated at the dose of CHR-2797 under a separate protocol.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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