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

NCT00982111

NCT00982111
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with a specific type of non-small cell lung cancer (not the squamous type — for example, adenocarcinoma or large cell) confirmed by a lab test
  • Your cancer is at Stage IV (meaning it has spread) at the time you would enter the study
  • Your cancer can be measured or detected on scans (at least some disease must be measurable)
  • Any side effects from previous cancer treatments (such as chemotherapy, surgery, radiation, or hormone therapy) have mostly resolved, except for hair loss
  • You are well enough to carry out light activity and care for yourself (a doctor will assess this using a standard scale)
  • Your liver, kidneys, and blood counts are working at adequate levels
  • If you are a woman who could become pregnant, you must use a highly effective form of birth control during treatment and for 6 months afterward — the pill alone is not enough and must be combined with a barrier method (such as a condom)
  • If you are a man, you must use effective contraception during treatment and for 6 months afterward, unless you have had a procedure to prevent fathering children
  • Women who could become pregnant must have a negative pregnancy blood test before joining

Who may not be able to join:

  • You have the squamous type of non-small cell lung cancer
  • You have previously been treated with certain targeted therapies, including monoclonal antibodies or treatments aimed at EGFR, VEGF, or VEGF receptors (confirm with trial site if unsure)
  • You have already received chemotherapy for advanced lung cancer (though prior chemotherapy given after surgery may be acceptable if it was completed at least 1 year before joining)
  • You have had major surgery or taken part in another experimental treatment study within the last 4 weeks
  • You have had radiation to your chest within the last 12 weeks (radiation to bones for pain relief is generally allowed)
  • You have brain metastases (cancer that has spread to the brain) that are causing symptoms or require ongoing treatment with steroids or anti-seizure medication
  • You have a blockage of a major vein in your chest (superior vena cava syndrome) that makes it unsafe to receive extra fluids
  • You have significant heart artery disease or uncontrolled heart failure
  • You have had a heart attack within the last 6 months
  • You currently have an active infection requiring antibiotics, active tuberculosis, or HIV
  • You have a significant history of neurological or psychiatric conditions (such as dementia, seizures, or bipolar disorder) that could affect your ability to take part in the study
  • You have moderate or severe nerve damage causing numbness, tingling, or pain (Grade 2 or higher peripheral neuropathy)
  • You have significant fluid build-up in body cavities that needs to be drained repeatedly
  • You have any other serious uncontrolled medical or psychological condition that, in the doctor's opinion, would prevent you from completing the study
  • You have a known allergy or serious reaction to any ingredient in the study treatments
  • You are currently pregnant or breastfeeding
  • You have a known history of drug abuse
  • You currently have another active cancer (with the exception of certain treated skin cancers or early-stage cervical changes)
  • You have had a different cancer in the past, unless you have been cancer-free for at least 3 years

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 3: approximately ~65% 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 3
Sponsor
Eli Lilly and Company
Registry
clinicaltrials_gov
Start date
2 November 2009
Est. completion
14 November 2012

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇭🇷 Croatia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇵🇱 Poland 🇵🇹 Portugal 🇷🇴 Romania 🇷🇺 Russia 🇸🇰 Slovakia 🇿🇦 South Africa 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Overall Survival Time (OS)

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