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Lung cancer drug combo fails to extend survival in major trial

NCT ID NCT00532155

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This large Phase 3 trial tested whether adding aflibercept (a drug that blocks blood vessel growth) to standard chemotherapy (docetaxel) could help people with advanced non-small cell lung cancer live longer. Over 900 participants who had already tried one platinum-based treatment were randomly assigned to receive either aflibercept or a placebo, plus docetaxel. The study found that the combination did not improve overall survival compared to chemotherapy alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aflibercept (a drug that blocks blood vessel growth, combined with chemotherapy docetaxel)
What this could lead to
If it had worked, this could have pointed toward a new treatment option for advanced non-small cell lung cancer after first-line therapy fails.
What could go wrong
This large Phase 3 trial found that adding aflibercept to docetaxel did not improve overall survival compared to placebo. The study is complete, so the results are final and not promising for this combination.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

913 people

The number who actually took part.

Start date

Sep 2007

Finished

Oct 2011

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histological/cytological proven locally advanced or metastatic non-small cell lung cancer * Disease progression during or after one, and only one, prior anticancer therapy which is platinum-based for advanced or metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * Adequate renal, liver and bone marrow functions Exclusion Criteria: * Squamous histology/cytology * Less than 28 days elapsed from prior treatment with radiotherapy, surgery, or chemotherapy to the time of randomization * Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to \> 25% of bone marrow * Prior docetaxel treatment * Uncontrolled hypertension The above information was not intended to contain all considerations relevant to participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

carcinoma lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma Non-small-cell lung

Contacts and locations

Locations

  • Sanofi-Aventis Administraive Office

    Istanbul, Turkey (Türkiye)

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey, 08807, United States

  • Sanofi-Aventis Administrative Office

    Buenos Aires, Argentina

  • Sanofi-Aventis Administrative Office

    Vienna, Austria

  • Sanofi-Aventis Administrative Office

    São Paulo, Brazil

  • Sanofi-Aventis Administrative Office

    Sofia, Bulgaria

  • Sanofi-Aventis Administrative Office

    Laval, Canada

  • Sanofi-Aventis Administrative Office

    Santiago, Chile

  • Sanofi-Aventis Administrative Office

    Shanghai, China

  • Sanofi-Aventis Administrative Office

    Prague, Czechia

  • Sanofi-Aventis Administrative Office

    Tallinn, Estonia

  • Sanofi-Aventis Administrative Office

    Helsinki, Finland

  • Sanofi-Aventis Administrative Office

    Paris, France

  • Sanofi-Aventis Administrative Office

    Berlin, Germany

  • Sanofi-Aventis Administrative Office

    Athens, Greece

  • Sanofi-Aventis Administrative Office

    Causeway Bay, Hong Kong

  • Sanofi-Aventis Administrative Office

    Budapest, Hungary

  • Sanofi-Aventis Administrative Office

    Mumbai, India

  • Sanofi-Aventis Administrative Office

    Milan, Italy

  • Sanofi-Aventis Administrative Office

    Kuala Lumpur, Malaysia

  • Sanofi-Aventis Administrative Office

    Gouda, Netherlands

  • Sanofi-Aventis Administrative Office

    Warsaw, Poland

  • Sanofi-Aventis Administrative Office

    Porto Salvo, Portugal

  • Sanofi-Aventis Administrative Office

    Bucharest, Romania

  • Sanofi-Aventis Administrative Office

    Moscow, Russia

  • Sanofi-Aventis Administrative Office

    Singapore, Singapore

  • Sanofi-Aventis Administrative Office

    Seoul, South Korea

  • Sanofi-Aventis Administrative Office

    Barcelona, Spain

  • Sanofi-Aventis Administrative Office

    Bromma, Sweden

  • Sanofi-Aventis Administrative Office

    Taipei, Taiwan

  • Sanofi-Aventis Admnistrative Office

    Guildford Surrey, United Kingdom

  • sanofi-aventis Australia & New Zealand administrative office

    Macquarie Park, New South Wales, Australia

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