A randomized, blinded, placebo-controlled Phase IIb/III study to evaluate the effect of ACT001 on efficacy of WBRT and radiation-associated side effects in lung cancer patients with brain metastasis

INTERVENTION: Treatment group:ACT001 400 mg BID+ whole brain Radiation Therapy;Placebo group:Placebo, BID plus whole brain radiation therapy; CONDITION: Small cell lung cancer and non‐small cell lung cancer with brain metastases PRIMARY OUTCOME: Objective response rate of intracranial tumor within 3 months (ORR); SECONDARY OUTCOME: Overall survival (OS);Intracranial tumor progression time (TTP);Depth of remission of intracranial tumor (DPR);Incidence of serious adverse events (SAE);The QLQ‐C30 score has changed;Incidence of late neurological impairment events caused by WBRT;Proportion of subjects interviewed 12 weeks after completion of radiotherapy;Incidence of =2 grade WBRT‐associated AE;PK parameters for single and multiple administration; INCLUSION CRITERIA: To be included in this study, the following inclusion criteria must be met: 1. Patients with histologically or cytologically confirmed lung cancer (small cell lung cancer and non‐small cell lung cancer) with brain metastases: small cell lung cancer: two lines above treatment, and patients with brain metastasis; non‐small cell lung cancer: drive negative genetic only.Second‐line treatment and above with brain metastases. 2. Subjects assessed by the investigators could receive whole brain radiation therapy. 3. > 3 brain metastases (small cell lung cancer patients do not limit the number of brain metastases). 4. Confirm that there is at least one measurable lesion in the brain according to RECIST v1.1 criteria (as determined by radiologists and clinicians) : maximum measurable lesions is not more than 4 cm diameter (< for > 4 cm and 6 cm do after lesions and consider into the group of local plus the amount of radiation, the researchers can a