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Comparing tarlatamab with standard chemotherapy in patients with pre-treated advanced pulmonary or gastroenteropancreatic neuroendocrine carcinomas

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with advanced pulmonary or gastroenteropancreatic poorly differentiated neuroendocrine carcinomas (NECs) who have previously received treatment with platinum-based chemotherapy. The main treatment being investigated is tarlatamab, which will be compared to standard chemotherapy treatments including oxaliplatin, dacarbazine, docetaxel, temozolomide, irinotecan, and fluorouracil. Some patients may also receive immunotherapy medications like atezolizumab, nivolumab, or pembrolizumab.

The purpose of this research is to evaluate how well tarlatamab works compared to standard chemotherapy treatments in treating this type of cancer. The study will measure how long patients survive after receiving treatment. The medication will be given through an infusion into a vein.

During the study, doctors will monitor patients' response to treatment using imaging scans and blood tests. They will also track any side effects that occur and evaluate patients' quality of life using questionnaires. The study is expected to last for approximately 24 months per patient.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and group assignment

    Your eligibility for the study will be confirmed after meeting specific health criteria, including adequate organ function and recovery from previous treatments

    You will be randomly assigned to receive either tarlatamab or standard chemotherapy treatment

  2. Step 2

    Treatment administration

    If assigned to tarlatamab group: you will receive the medication through intravenous infusion

    If assigned to standard chemotherapy group: you may receive one of the following medications through infusion or orally:

    - Oxaliplatin (intravenous infusion)

    - Dacarbazine (intravenous infusion)

    - Docetaxel (intravenous infusion)

    - Temozolomide (oral capsules)

    - Topotecan (intravenous infusion)

    - Irinotecan (intravenous infusion)

    - Fluorouracil (intravenous infusion)

  3. Step 3

    Regular monitoring

    Your response to treatment will be assessed through regular medical examinations

    Imaging scans will be performed to measure tumor response

    Side effects will be monitored and recorded throughout the treatment period

    You will complete quality of life questionnaires during the study

  4. Step 4

    Follow-up period

    Your health status will continue to be monitored after completing treatment

    Regular check-ups will track your overall survival and disease progression

    The study is expected to continue until March 2028

Who can join the trial?

16 criteria

  • Must be at least 18 years old
  • Must sign an informed consent form showing understanding and willingness to participate in the study
  • Must have adequate organ function, including: - Healthy kidney function - Normal blood cell counts - Acceptable liver function tests
  • Must have recovered from side effects of previous treatments
  • Must provide tumor tissue samples for research purposes
  • Must be in stable health condition without any factors that could interfere with study participation
  • Must have a WHO Performance status of 0-1 (able to perform daily activities with minimal limitations)
  • Must have a life expectancy of more than 12 weeks
  • Must have confirmed poorly differentiated neuroendocrine carcinoma (NEC) that has been verified by specialists
  • Must have tumors that express a specific protein called DLL3 in at least 1% of cells
  • Must have disease progression after receiving platinum-based chemotherapy
  • Must have cancer that cannot be surgically removed or has spread to other parts of the body
  • Must have at least one measurable tumor that can be tracked during the study
  • Women who can become pregnant must use effective birth control for 28 days before starting treatment and 7 months after the last dose
  • Men with partners who can become pregnant must use birth control for 6 months after the last dose
  • Must have national health insurance coverage

Who cannot join the trial?

12 criteria

  • History of central nervous system metastases (spread of cancer to the brain or spinal cord), unless treated and stable for at least 4 weeks
  • Active or prior autoimmune disease (condition where immune system attacks healthy cells) requiring systemic treatment within the past 2 years
  • Previous treatment with any DLL3-targeted therapy (specific type of cancer treatment)
  • Presence of other active cancers requiring treatment
  • Significant heart conditions including heart failure, unstable heart rhythm, or heart attack within the past 6 months
  • Active or uncontrolled infections
  • Impaired liver function (liver not working properly) or active liver disease
  • Pregnancy or breastfeeding
  • Known HIV infection or active hepatitis B or C
  • Major surgery within 4 weeks before starting the study treatment
  • Participation in other clinical trials within 4 weeks before starting this study
  • Any condition that, in the opinion of the study doctor, would interfere with the safe conduct of the study
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Investigated drugs

  • Tarlatamab

    is a new investigational medication being studied for treating advanced neuroendocrine carcinomas that affect either the lungs or digestive system (including stomach, pancreas, and intestines). This medication is being tested in patients whose cancer has not responded well enough to previous chemotherapy treatments that contained platinum. Tarlatamab represents a new approach to treating these types of cancers.

  • Standard chemotherapy

    refers to conventional cancer-fighting medications that are currently approved and commonly used to treat neuroendocrine carcinomas. These are the established treatments that doctors typically prescribe for this type of cancer, and in this study, they are being compared to tarlatamab to see which approach works better.

What is already known about the treatment

Tarlatamab - A novel investigational bispecific antibody medication administered through intravenous infusion, currently being studied in clinical trials for the treatment of advanced pulmonary and gastroenteropancreatic neuroendocrine carcinomas (NECs). The drug is being evaluated as a second-line treatment option for patients who have previously received platinum-based chemotherapy, representing a potential alternative to standard chemotherapy regimens. As a bispecific antibody, tarlatamab works by simultaneously binding to two different targets, potentially enhancing the body's immune response against cancer cells, though its exact molecular mechanism of action is still being investigated through ongoing clinical research. Note: Since only one investigational medication (tarlatamab) was mentioned in the trial data, I provided just one description.

Investigated diseases

Neuroendocrine Carcinoma (NEC) – A type of cancer that develops from specialized cells called neuroendocrine cells, which have traits of both nerve cells and hormone-producing cells. This cancer can occur in various parts of the body, but this description focuses on pulmonary (lung) and gastroenteropancreatic (digestive system) locations. NECs are characterized by rapid cell growth and can spread to other parts of the body. The disease typically affects the hormone-producing system of organs, disrupting normal hormonal balance. These tumors can develop in the lungs, pancreas, stomach, and intestines. The cancer cells in NECs tend to grow more quickly than other types of neuroendocrine tumors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515948-23-00Protocol codeGCO-003 TARLANECEstimated enrolment129 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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