Clinical Trial: Triplet Combination First Line Treatment in Non Small Cell Lung Cancer (NSCLC)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First Line Treatment in Patients With Locally Advanced (Stage IIIB With Malignant Pleural Effusion or This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule.

The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy.

The combination of cisplatin/pemetrexed has come to be recognized as the new standard of care for patients with untreated, unresectable malignant pleural mesothelioma (MPM) and untreated NSCLC non-squamous cell histology.

Preclinical and clinical findings that support this protocol are:

  • CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.
  • Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines.
  • The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination,

    Detailed Summary:
    Sponsor: CanBas Co. Ltd.

    Current Primary Outcome: The primary efficacy endpoint is Progression free survival, analyzed in the treated population. PFS is assessed from randomization until either tumor progression, as per RECIST criteria, or until death due to any reason.

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Objective response rate (CR + PR): response is to be assessed according to RECIST criteria (see Section 7.1), with responses to be confirmed at least 4 weeks after the first observation of response.
    • Duration of response is assessed in patients with confirmed response, from the first documentation of response until the first occurrence of disease progression. In case of death due to reasons other than disease progression, patie
    • Rate of tumor growth control (TGC): patients with tumor growth control are those patients who experience confirmed response (CR or PR) or stable disease lasting at least 12 weeks.
    • Duration of tumor growth control: duration of TGC is assessed from randomization to the first occurrence of disease progression or death in patients with confirmed TGC.
    • Overall survival: OS is assessed from randomization until the date of death from any cause.
    • Incidence and severity of adverse events and laboratory abnormalities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 3.0
    • Occurrence of Serious Adverse Events.
    • Occurrence of treatment discontinuation due to adverse events.


    Original Secondary Outcome: Same as current

    Information By: CanBas Co. Ltd.

    Dates:
    Date Received: July 17, 2009
    Date Started: April 2009
    Date Completion:
    Last Updated: July 29, 2013
    Last Verified: July 2013