Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are at least 18 years old at the time of signing the consent form
• People whose general health and ability to carry out daily activities meets a specific standard (a score of 0 or 1 on a scale doctors use to measure this)
• People who have been diagnosed with small cell lung cancer (SCLC) that started in the lungs, confirmed through a tissue or cell sample, and whose disease can be measured using standard imaging guidelines
• People whose cancer is classified as "limited-stage," meaning it has not spread widely, as confirmed by a PET scan done before starting treatment
• People who have completed combined chemotherapy and radiation therapy for limited-stage SCLC without the cancer getting worse, within the 42 days before joining the trial
• People whose chemotherapy included a platinum-based drug and etoposide given through a drip, and who received at least 3 cycles of chemotherapy
• People whose radiation therapy was given according to their hospital's standard guidelines
• People who may or may not have received preventive brain radiation (called PCI) — if they did receive it, it must have been completed between 14 and 42 days before joining the trial
• People whose blood counts and organ function meet the required health thresholds
• People who are willing to follow the contraception requirements set out in the trial protocol for the entire duration of the study

Who may not be able to join:

• People whose small cell cancer started somewhere other than the lungs
• People diagnosed with large cell neuroendocrine carcinoma
• People with extensive-stage SCLC (meaning the cancer has spread more widely)
• People whose cancer has mixed features of SCLC and another lung cancer type (NSCLC), or who have a specific type of NSCLC that has changed into SCLC
• People who have had a severe allergic reaction to monoclonal antibody treatments in the past
• People with a known allergy to any ingredients in the study drugs (atigotatug, nivolumab, or durvalumab)
• People with moderate or severe nerve damage in their hands or feet (Grade 2 or higher on a standard medical scale)
• People with an active, past, or suspected autoimmune disease, including certain nerve-related autoimmune conditions — though some exceptions may apply, such as type 1 diabetes, an underactive thyroid managed with hormone replacement, certain skin conditions not needing systemic treatment, or autoimmune conditions not expected to come back during the study
• People who have needed ongoing steroid tablets at higher doses (more than 10 mg of prednisone daily or equivalent) or other immune-suppressing medications within 14 days of starting the study — short courses of lower-dose steroids and certain inhaled or topical steroids may be permitted (confirm with trial site)
• People who have had an organ transplant or bone marrow transplant
• People with a history of moderate or severe lung inflammation (pneumonitis), unless it was caused by an infection and has fully resolved
• People with certain heart conditions currently or within the last 3 months, including:
  • Significant abnormalities in heart rhythm or electrical activity on an ECG
  • Moderate to severe heart failure
  • Conditions or medications that increase the risk of a specific type of dangerous heart rhythm (QT prolongation)
  • A heart pumping function below 55% or below the normal range set by the treating hospital
  • High blood pressure that is not well controlled despite medication
  • Active coronary artery disease, including unstable or newly diagnosed chest pain (angina)
  • A recent heart attack
  • A history of serious irregular heart rhythms
  • A current or past diagnosis of heart muscle inflammation (myocarditis)
• People with other serious or uncontrolled medical conditions, as assessed by the treating doctor
• People with another active invasive cancer — people who were treated for a different cancer may be considered if treatment finished at least 2 years before screening and there is no sign of that cancer returning; some exceptions apply for certain low-risk or locally treated cancers (confirm with trial site)
• People whose chemotherapy and radiation for limited-stage SCLC were given one after the other (sequentially) rather than at the same time
• People who have received certain recent treatments, including:
  • Systemic cancer treatment within 21 days or 5 half-lives of the first study dose (whichever is longer)
  • Wide-field radiation within 28 days, or limited palliative radiation within 7 days, of starting the study
  • Any prior systemic treatment for limited-stage SCLC other than the chemoradiation and preventive brain radiation described above
  • Prior treatment with certain immune checkpoint or T-cell targeting drugs (such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or similar therapies)
  • Prior treatment with a specific type of vaccine targeting ganglioside antigens (such as fuc-GM-1 vaccine)
  • Current use of immune-suppressing medications
  • A live attenuated vaccine within 100 days before the first study dose
• People who have had major surgery (not including placement of a drip line) within 4 weeks of the screening visit
• People who still have side effects from previous treatment that have not resolved to a mild level — with some exceptions for certain ongoing manageable side effects, subject to approval by the trial's medical team (confirm with trial site)
• People whose personal, family, social, or location-related circumstances would make it difficult to follow the trial's requirements and attend follow-up visits

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