Phase 3 Lung Cancer Trial, Completed NCT00982111 Sponsor: Eli Lilly and Company Condition: Lung Cancer
Back to Lung Cancer

Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 315 people in the necitumumab plus pemetrexed plus cisplatin group, and 318 people in the pemetrexed plus cisplatin (chemotherapy only) group. The trial was looking at whether adding a medicine called necitumumab to a standard two-drug chemotherapy combination made a difference for people with a type of lung cancer called non-squamous non-small cell lung cancer. The main thing being measured was how long participants lived overall, and several other things were also tracked, including how long before the cancer started growing again, how many participants' tumours shrank, and how long participants stayed on treatment. The reported data shows that for overall survival — the time from entering the trial until death from any cause — the median (the midpoint value across all participants) was 11.3 months in the necitumumab plus chemotherapy group and 11.5 months in the chemotherapy-only group. For progression-free survival — the time until the cancer was seen to be growing or until death — both groups had a reported median of 5.6 months. When looking at tumour shrinkage, about 31.1% of participants in the necitumumab group and 32.1% in the chemotherapy-only group had their tumours shrink meaningfully. The time to treatment failure — how long before treatment stopped working or was stopped — was reported as 3.5 months in the necitumumab group and 4.3 months in the chemotherapy-only group. The reported data also shows that 37 participants in the necitumumab group were assessed for antibodies to the drug, of whom 18 were found to have developed them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Lung Cancer Trial, Completed

NCT00982111
Completed Phase 3 🇦🇺 Australian site

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • 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

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
2 November 2009
Est. completion
14 November 2012

Where this trial was run

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

These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Overall Survival Time (OS)

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov