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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01466660

NCT01466660
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with advanced lung cancer (stage IIIB or IV) of a specific type called adenocarcinoma, confirmed by a lab test.
  • Your tumour has been tested and found to have a specific gene change (mutation) in the EGFR gene, specifically called Del19 and/or L858R.
  • You have at least one tumour that can be measured on a scan.
  • You are generally well enough to carry out light activity and care for yourself (your doctor will assess this using a standard scale).
  • You are 18 years of age or older.
  • Your liver, kidneys, and blood cell counts are within acceptable ranges based on recent blood tests.

Who may not be able to join:

  • You have already had chemotherapy for advanced (stage IIIB or IV) lung cancer (earlier chemotherapy for a different stage may be allowed if it was more than 12 months ago).
  • You have previously been treated with medicines that target the EGFR gene (small molecule drugs or antibodies).
  • You had major surgery within the last 4 weeks.
  • You currently have active cancer spread to the brain.
  • You have cancer that has spread to the membranes surrounding the brain or spinal cord.
  • You have or have had another type of cancer, with some exceptions such as certain treated skin cancers or cancers that have been fully in remission for more than 3 years (confirm with trial site).
  • You have a known pre-existing lung condition called interstitial lung disease.
  • You have significant heart or cardiovascular problems, as assessed by your doctor.
  • Your heart's pumping function is below the normal range for the hospital running the trial.
  • You are a woman who could become pregnant, or a man who could father a child, and you are unwilling to use reliable contraception or remain abstinent during the trial and for at least 2 months after treatment ends.
  • You are currently pregnant or breastfeeding.
  • You have active hepatitis or are known to carry the HIV virus.
  • You are taking certain medications that are not permitted alongside the trial drugs afatinib or gefitinib (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Boehringer Ingelheim
Registry
clinicaltrials_gov
Start date
13 December 2011
Est. completion
8 April 2016

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇫🇷 France 🇩🇪 Germany Hong Kong 🇮🇪 Ireland 🇳🇴 Norway 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇬🇧 United Kingdom

7 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression-free Survival; Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016); Overall Survival

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov