Adjuvant Therapy with Pembrolizumab Versus Placebo in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation

Gender:
Female: yes
Male: yes

Inclusion criteria:
- Histologically confirmed non-squamous NSCLC, stage IIIB/C (not amenable to radical therapy) or stage IV according to 8th TNM classification
- Presence of the sensitising EGFR-mutation (only patients with exon 19 deletion and/or L858R are eligible) and documentation of T790M status, tested locally by an accredited laboratory.
- Radiologically confirmed disease progression on previous treatment with osimertinib or lazertinib.
Treatment with osimertinib or lazertinib must have been stopped at least 8 days before enrolment.
- Achieved objective clinical benefit from osimertinib or lazertinib treatment (e.g., documented PR/ CR or SD for =6 months while on osimertinib or lazertinib treatment).
- Measurable disease as defined according to RECIST v1.1.
- Age =18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Life expectancy =12 weeks
- Adequate haematological, renal and liver function.
- Written Informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
- Patients with known small cell lung carcinoma (SCLC) transformation.
- Patients with symptomatic brain metastases.
Patients with asymptomatic or previously treated and stable brain metastases may participate in this study. Patients who have received definitive radiotherapy or surgery for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at =2 weeks before enrolment are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (=10 mg/day prednisone or equivalent) for at least 2 weeks prior to enrolment.
- Patients with an active or past medical history of leptomeningeal disease.
- Patients with untreated spinal cord compression.
Patients who have been definitively treated with surgery or radiotherapy and have a stable neurological status for =2 weeks prior to enrollment are eligible provided they are off corticosteroid treatment or are receiving low-dose corticosteroid treatment =10 mg/day prednisone or equivalent.
- Patients with unresolved adverse events (other than alopecia) from prior anticancer therapy that have not resolved to grade =1 or baseline.
- Patients with positive hepatitis B or hepatitis C antibody.
- Patients with other clinical active infectious liver disease.
- Patients who ar positive for HIV.
- Patients with active cardiovascular disease.
- Patients with interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis.
- Patient with a history of haemoptysis (=2.5 mL of bright red blood per episode) within 1 month prior to enrolment.
- Patients with evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
- Patients with current or recent (within 10 days before enrolment) use of aspirin (>325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and clostazol.
- Patients with current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for >2 weeks prior to enrolment.
- Patients with serious, non-healing wound, active ulcer, or untreated bone fracture.
- Patients who had a core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to enrolment.
- Patients who had major surgery or significant traumatic injury within 28 days prior to enrolment.
- Patients who had placement of a vascular access device within 2 days prior to prior to enrolment.
- Patients with a history of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to enrolment.
- Patients with clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
- Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
- Patients with concurrent or prior malignancy other than the disease under study.
- Patients with uncontrolled illness.
- History of hypersensitivity to either the drug substance or any excipients in amivantamab, lazertinib and/ or bevacizumab.
- Prior chemotherapy.
- Prior treatment with bevacizumab or another anti-angiogenic inhibitor.
- Prior treatment with a MET/EGFR-targeting antibody.
- Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Women who are pregnan