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

NCT01606748

NCT01606748
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • You have an advanced or spreading solid tumor cancer (not colorectal cancer with a KRAS mutation) that has stopped responding to standard treatments, or no standard treatment is available for your cancer.
  • Your cancer may or may not have measurable tumors on scans.
  • Any serious side effects from previous cancer treatments (such as chemotherapy, surgery, radiation, or hormone therapy) have mostly or fully cleared up, except for hair loss.
  • You are generally well enough to carry out light activity and care for yourself (confirm with trial site what this level of fitness means for you).
  • Your liver, kidneys, and blood counts are at healthy enough levels.
  • If you are a woman who could become pregnant, you agree to use highly effective birth control during the trial and for 6 months after, or you have had surgery to prevent pregnancy, or you are past menopause.
  • If you are a man, you have had surgery to prevent fathering a child, or you agree to use highly effective birth control during and for 6 months after the trial.
  • If you are a woman who could become pregnant, you have had a negative blood pregnancy test within 7 days before starting the trial treatment.

Who may not be able to join:

  • You have received any systemic cancer treatment (including certain targeted therapy pills) or a medical device for cancer within the past 28 days.
  • Your most recent cancer treatment included the chemotherapy drugs gemcitabine or cisplatin (or both).
  • You have had radiation therapy within the past 14 days.
  • You have had chemotherapy within the past 21 days.
  • You are currently receiving any other cancer treatment, such as chemotherapy, immunotherapy, hormone therapy, radiation, or targeted therapy.
  • Your cancer could potentially be removed by surgery.
  • You have cancer that has spread to the brain and is causing symptoms, or requires steroids or seizure medication to manage.
  • You have a blockage or narrowing in a major vein in your body.
  • You have coronary artery disease or heart failure that is not well controlled.
  • You have uncontrolled chest pain (angina), or you had a heart attack within the past 6 months.
  • You have an active infection that requires treatment, including active tuberculosis or HIV.
  • You have a significant history of neurological or psychiatric conditions such as dementia, seizures, or bipolar disorder.
  • You have a known problem with drug or alcohol abuse.
  • You are pregnant or currently breastfeeding.
  • You have had major surgery within the past 28 days, or a port/venous access device placed under the skin within the past 7 days.
  • You are currently in another clinical trial, or left one within the past 30 days, or are involved in other medical research that may conflict with this study.

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
Eli Lilly and Company
Registry
clinicaltrials_gov
Start date
1 August 2012
Est. completion
1 June 2013

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Necitumumab; PK: Dose-Normalized Cmax of Gemcitabine; PK: Dose-Normalized Cmax of Cisplatin; PK: Area Under Concentration-Time Curve From Zero to Time 168 (AUC[-168]) of Necitumumab; PK: Dose-Normalized AUC(0-24) of Gemcitabine; PK: Dose-Normalized AUC(0-5) of Cisplatin; PK: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity, (AUC[0-∞]) of Necitumumab; PK: Dose Normalized AUC(0-∞) of Gemcitabine

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