Study of the novel cancer drug GDC-0941 (or placebo) in combination with : a) the approved anticancer drugs carboplatin and paclitaxel; and b) the approved anticancer drugs carboplatin, paclitaxel and...

Update Il y a 4 ans
Reference: EUCTR2011-002893-21

Study of the novel cancer drug GDC-0941 (or placebo) in combination with : a) the approved anticancer drugs carboplatin and paclitaxel; and b) the approved anticancer drugs carboplatin, paclitaxel and bevacizumab in previously untreated patients with advanced non-small cell lung cancer

Woman and Man

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Extract

Part I •To evaluate the efficacy (as measured by PFS) of GDC-0941 340mg+carboplatin+paclitaxel (Arm A) versus carboplatin+paclitaxel (Arm B) in all patients with squamous NSCLC •To evaluate the efficacy (as measured by PFS) of GDC-0941 340mg+carboplatin+paclitaxel (Arm A) versus carboplatin+paclitaxel (Arm B) in patients with squamous NSCLC with PIK3CA amplification •To evaluate the efficacy (as measured by PFS) of GDC-0941 340mg+carboplatin+paclitaxel+bevacizumab (Arm C) versus carboplatin+paclitaxel+bevacizumab (Arm D) in all patients with non-squamous NSCLC •To evaluate the efficacy (as measured by PFS) of GDC-0941 340mg+carboplatin+paclitaxel+bevacizumab (Arm C) versus carboplatin+paclitaxel+bevacizumab (Arm D) in patients with non-squamous NSCLC with PTEN-loss/low status Part II •To evaluate the efficacy (as measured by PFS) of GDC-0941 260mg+ carboplatin+paclitaxel+bevacizumab (Arm E) versus carboplatin+paclitaxel+bevacizumab (Arm F) in all patients with non-squamous NSCLC


Inclusion criteria

  • Previously untreated advanced or recurrent non-small cell lung cancer