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 18 years of age or older at the time of registration.
• People diagnosed with extensive-stage small cell lung cancer (a form of lung cancer that has spread) who are either about to start, or have already begun (but completed no more than 3 cycles of), a standard chemotherapy combination (platinum plus etoposide) together with a drug called durvalumab.
• People who have not received any prior immunotherapy for their small cell lung cancer before starting this frontline treatment.
• People who are physically well enough to safely receive the planned chemotherapy and immunotherapy, as judged by their treating doctor (Zubrod performance status of 0–2).
• People who have fully recovered from any prior surgery before joining the trial.
• People who have tumor tissue available from their small cell lung cancer diagnosis that can be submitted for testing, and who agree to allow any leftover tissue to be kept for future research.
• People who have signed an informed consent form agreeing to take part in this research study (or, where decision-making is impaired, whose legally authorised representative has done so).
• People whose tumor tissue has been tested and assigned to a specific subtype (A, N, I, or P) by the designated laboratory (BostonGene), as confirmed before the second registration step.
• People whose cancer has been assessed by a CT scan of the chest, abdomen, and pelvis (with contrast unless not safe), and a CT or MRI scan of the brain, within the required timeframes before the second registration step.
• People whose cancer did not progress during induction treatment.
• People who have completed the full course of induction therapy (4–6 cycles of platinum plus etoposide, with 4 cycles of durvalumab given in combination).
• People who weigh more than 30 kg at the second registration step.
• People with blood test results within acceptable ranges before the second registration step, including: haemoglobin above 9.0 g/dL; neutrophil count at or above 1.5 x 10³/uL; platelet count at or above 100 x 10³/uL; liver function and bilirubin levels within acceptable limits; and kidney function within acceptable limits.
• People with HIV who are on effective antiviral treatment and have an undetectable viral load within the 6 months before the second registration step.
• People with a history of chronic hepatitis B who are on suppressive therapy and have an undetectable viral load within the 6 months before the second registration step (if applicable).
• People with a history of hepatitis C who have been successfully treated or are currently being treated and have an undetectable viral load within the 6 months before the second registration step (if applicable).
• People who agree to use effective contraception during the trial and for 6 months after completing treatment, if they are of reproductive potential.
• People who are offered the opportunity to participate in specimen banking (storing biological samples for research).

Who may not be able to join:

• People who have or have had another cancer whose history or treatment could interfere with the safety or assessment of this trial, in the opinion of their treating doctor.
• People with a previous history of limited-stage small cell lung cancer.
• People who received any immunotherapy drug other than durvalumab as part of their frontline induction treatment — for example, atezolizumab, pembrolizumab, or nivolumab.
• People who received any experimental (investigational) treatment for their small cell lung cancer prior to this trial.
• People who plan to receive additional cancer treatments (chemotherapy, immunotherapy, biologic, or hormonal therapy) outside of what this trial protocol specifies, while enrolled in the trial (note: bone-strengthening drugs called bisphosphonates are allowed for people with bone metastases).
• People who still have unresolved side effects rated grade 2 or worse from previous cancer treatment, except for hair loss or a skin pigmentation condition called vitiligo.
• People who have had an organ transplant from another person (allogeneic transplant).
• People with medical reasons they cannot receive immunotherapy, including a history of non-infectious lung inflammation that required steroid treatment, or an active autoimmune disease that has required systemic treatment within the past two years (note: standard hormone replacement therapies and intra-articular steroid injections are not considered disqualifying).
• People who are currently pregnant or breastfeeding, or who plan to breastfeed during the trial or for 6 months after completing treatment.
• People whose brain metastases (cancer that has spread to the brain) are active, symptomatic, or causing neurological problems — unless the metastases have been treated, are stable, and the person has been off steroids for at least 24 hours before the second registration step.
• People who have leptomeningeal disease (cancer spreading along the lining of the brain and spinal cord) or spinal cord compression that does not meet the above exceptions (confirm with trial site).
• People who experienced a serious immune-related side effect (grade 3 or worse) during induction treatment, or an unresolved grade 2 immune-related side effect, or who had to permanently stop durvalumab due to a side effect.
• People who received a live or live-attenuated vaccine within 30 days before the second registration step — examples include measles, mumps, rubella, chickenpox/shingles, yellow fever, rabies, BCG, typhoid, and nasal flu spray vaccines (note: standard flu shots and COVID-19 vaccines are allowed).
• People who received prophylactic cranial irradiation (preventive radiation to the brain).

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