A Safety and Efficacy Study of Farletuzumab in Subjects With Adenocarcinoma of the Lung

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Adenocarcinoma of lung
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Boehringer Ingelheim – Adenocarcinoma of lung
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Brief Title

A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum-Containing Doublet in Chemotherapy-Naive Subjects With Stage IV Adenocarcinoma of the Lung (FLAIR)

Brief Summary

      The primary objective of this study is to compare the effect of farletuzumab versus placebo
      in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent
      (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on
      investigator-assessed progression free survival (PFS) as determined by Response Evaluation
      Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new
      occurrence of positive fluid cytology) in chemotherapy naive participants with folate
      receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression-free Survival (PFS)

Secondary Outcome

 Overall Response Rate (ORR)

Condition

Adenocarcinoma of the Lung

Intervention

Farletuzumab

Study Arms / Comparison Groups

 Farletuzumab plus Chemotherapy
Description:  During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

130

Start Date

June 27, 2011

Completion Date

November 1, 2013

Primary Completion Date

December 15, 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the lung classified as
             stage IV

          -  Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)

          -  Measurable disease with at least one unidimensionally measurable lesion according to
             RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging
             (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the
             first dose of farletuzumab or placebo)

          -  Must have received no prior chemotherapy, radiation therapy or surgery with curative
             intent for adenocarcinoma of the lung

        Exclusion Criteria:

          -  Participants who have had previous chemotherapy for adenocarcinoma of the lung

          -  Prior surgery with curative intent for adenocarcinoma of the lung

          -  Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local
             radiotherapy for symptom control [i.e., palliative radiation with non-curative intent]
             is permitted)

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT01218516

Organization ID

MORAb-003-009

Secondary IDs

2010-022229-13

Responsible Party

Sponsor

Study Sponsor

Morphotek

Study Sponsor

, ,

Verification Date

March 2018