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 have been diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific genetic change called KRAS G12C, confirmed by an approved laboratory test done within the last 5 years
• People whose cancer has previously been treated with a KRAS G12C inhibitor, an immune checkpoint inhibitor, and chemotherapy (given together or separately), unless there was a medical reason they could not receive one or more of these treatments
• Records must be available showing which KRAS G12C inhibitor was used, when it was taken, and when the cancer progressed after the last treatment
• Records must also be available showing HER2 protein test results (including test date, method used, and scoring system) and HER2 gene mutation status from a tumour or blood test
• People who have measurable cancer that can be tracked using CT or MRI scans, according to standard measurement guidelines
• People aged 18 or older at the time of signing the consent form (children are excluded because safety data in this age group is not yet available for this drug combination)
• People who are well enough to carry out light activity and self-care, based on a standard health performance scale (ECOG score of 0, 1, or 2)
• People whose recent blood test results (taken within 14 days of joining) meet the required levels for red blood cells, white blood cells, neutrophils, and platelets — without having had a blood transfusion or certain blood-boosting injections in the week before the test
• People whose liver function blood tests, blood clotting tests, kidney function tests, and blood protein levels (taken within 14 days of joining) are within the required ranges
• People whose heart pumping function is at least 50%, confirmed by a heart scan within 28 days before joining
• People living with HIV who are on effective treatment and have had undetectable virus levels in the last 6 months
• People with a history of hepatitis B who have undetectable virus levels while on appropriate treatment
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have undetectable virus levels
• People who have had brain metastases that were treated with focused radiation (with at least 1 day since treatment) or whole-brain radiation (with at least 2 weeks since treatment)
• People with new or growing brain metastases, if the treating doctor determines that immediate brain-specific treatment is not needed during the first treatment cycle
• People with a life expectancy of at least 12 weeks
• People whose heart rhythm reading (QTc interval) is within the required range — up to 470 milliseconds for women and up to 450 milliseconds for men
• People who are willing and able to have a tumour biopsy taken before treatment starts (required for the Phase II expansion part of the trial; optional for the Phase I dose escalation part)
• People who are able to swallow and keep down oral (tablet) medications
• Women who could become pregnant must agree to use two forms of contraception and have a negative pregnancy test at screening; they must continue using contraception during the study and for 7 months after the last dose (noting that hormonal contraceptives alone may not be sufficient with this treatment, and a barrier method should also be used)
• Women who cannot become pregnant (due to surgical sterilisation or confirmed menopause) are also eligible; specific criteria apply for women on hormone replacement therapy (confirm with trial site)
• Men who are sexually active must agree to use effective barrier contraception during the study and for 4 months after the last dose, and must not donate or bank sperm from the start of screening until at least 4 months after the final dose (sperm preservation before joining the trial should be considered)
• Women must not donate eggs or retrieve eggs for personal use from screening until at least 7 months after the final dose
• People who are able to understand the study and are willing to sign a written consent form (a legally authorised representative may sign on behalf of the participant if needed)

Who may not be able to join:

• People who have had non-infectious lung scarring or inflammation (interstitial lung disease/ILD) that required steroid treatment, currently have ILD, or where ILD cannot be ruled out on imaging at screening
• People with serious lung problems caused by other lung conditions, including a blood clot in the lungs within the past 3 months, severe asthma, severe COPD, restrictive lung disease, or removal of an entire lung, or autoimmune or inflammatory conditions affecting the lungs
• People who have had radiation to the chest within the past 4 weeks (or 2 weeks for certain targeted palliative radiation treatments)
• People who have had major surgery and have not yet fully recovered
• People who have previously been treated with a certain type of antibody-drug therapy that works through a topoisomerase 1 inhibitor (such as sacituzumab govitecan, datopotamab deruxtecan, or trastuzumab deruxtecan), or with a topoisomerase inhibitor
• People who have needed systemic steroid treatment (more than 10 mg of prednisone daily) for a significant lung condition within the last 6 months
• People with significant corneal (eye surface) disease, as assessed by the treating doctor
• People with untreated and symptomatic spinal cord compression, or compression requiring steroids or anti-seizure medications to manage symptoms
• People with an active, uncontrolled infection requiring intravenous antibiotics, antiviral, or antifungal medications
• People who have not recovered from side effects of previous cancer treatment (side effects still at a moderate-to-severe level), with the exception of hair loss; some people with stable, long-term mild side effects may still be considered (confirm with trial site)
• People who are currently taking part in another clinical trial involving an investigational treatment
• People with a known allergic reaction to medications chemically similar to sotorasib (such as adagrasib) or trastuzumab deruxtecan
• People who have had a serious allergic reaction to other monoclonal antibody treatments
• People currently taking medications classified as strong CYP3A4 inducers (the trial site may consider switching to an alternative medication)
• People taking certain other medications that interact with the study drugs in ways that could cause serious side effects (confirm with trial site)
• People with other serious medical conditions that would make participation unsafe or interfere with the study results
• Women who are pregnant or breastfeeding (breastfeeding must be stopped if treatment is received)
• People with serious or uncontrolled heart conditions, including a heart attack within the last 6 months, significant heart failure, recent blood markers suggesting a heart attack, unstable chest pain, or serious abnormal heart rhythms
• People with a previous history of moderate or severe lung inflammation (pneumonitis grade 2 or higher) or ILD
• People who cannot receive both types of contrast dye used in CT and MRI scans
• People who have had fluid build-up around the lungs, in the abdomen, or around the heart that needed draining within 2 weeks of screening, or who have a peritoneal shunt or have undergone a specific fluid reinfusion procedure
• People who have received a live vaccine within 30 days before the first dose of study treatment (certain seasonal flu injections are generally acceptable; nasal spray flu vaccines are not)

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