A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC

  • STATUS
    Recruiting
  • End date
    Oct 25, 2023
  • participants needed
    216
  • sponsor
    Pfizer
Updated on 26 January 2021

Summary

The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-06439535 (CN) in combination with paclitaxel and carboplatin versus bevacizimab sourced from the European Union (bevacizumab-EU) with paclitaxel and carboplatin in Chinese participants with advanced non-squamous NSCLC in the first-line treatment setting.

Details
Condition Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC, Advanced Non-squamous NSCLC
Treatment carboplatin, Paclitaxel, Bevacizumab-EU, PF-06439535 (CN)
Clinical Study IdentifierNCT04325698
SponsorPfizer
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Advanced Non-squamous NSCLC?
Do you have any of these conditions: Do you have Advanced Non-squamous NSCLC??
Male and female participants age at least 18 years of age
Newly diagnosed Stage IIIB, IIIC or IV non small cell lung cancer (NSCLC) (according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition, last updated 05 June 2018) or recurrent NSCLC
Histologically or cytologically confirmed diagnosis of non-squamous NSCLC
At least one measurable lesion as defined by RECIST v1.1
Be eligible to receive bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC

Exclusion Criteria

Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas
Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that, in the opinion of the investigator, is likely to bleed
Known EGFR activating mutations (for example, exon 19 deletion or exon 21 L858R substitution mutations) or ALK rearrangements
Prior systemic therapy for advanced NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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