Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients (NCT05751187) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Pembrolizumab Plus Bevacizumab and Chemotherapy for Non-Squamous NSCLC Patients
China54 participantsStarted 2023-06-27
Plain-language summary
This study is designed to evaluate the efficacy and safety of Pembrolizumab in combination with Bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. According to the 8th edition of the AJCC/UICC TNM staging system for NSCLC, patients with locally advanced (stage III B/III C), metastatic or recurrent (stage IV) nonsquamous NSCLC confirmed by histology or cytology who are unable to undergo surgery and radical concomitant radiochemotherapy and are confirmed to have at least one measurable lesion according to RECIST 1.1.
✓. Patients harboring exon 20 insertions detected by ARMS or NGS or other approved methods.
✓. Age ≥18 years and ≤75 years.
✓. ECOG PS score: 0 to 1
✓. Have a life expectancy of at least 3 months.
✓. Have not received prior systemic treatment including chemotherapy, checkpoint inhibitors, TKIs, and anti-angiogenesis agents for their advanced/metastatic NSCLC. Subjects who received adjuvant or neoadjuvant therapy including immunotherapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of advanced/metastatic disease. Palliative radiotherapy must be completed 7 days before the first dose of study drugs and participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
✓. Have adequate organ function as defined in the following： (1) Adequate bone marrow function Absolute neutrophil count(ANC) ≥ 1500/uL; Platelets≥10x104/uL; Hemoglobin ≥9.0g/dL or ≥5.6 mmol/L; (2) Adequate kidney function Creatinine≤ 1.5 x upper normal limit (ULN), OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥30 mL/min for the participant with creatinine levels \>1.5 × institutional ULN (3) Adequate liver function Total bilirubin ≤ 1.5 x upper normal limit (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN; Aspartate Aminotransferase (AST) (SGOT) ≤ 2.5 xULN (≤ 5.0 x ULN if hepatic metastases); Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x ULN (≤ 5.0x ULN if hepatic metastases); (4) Coagulation function International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the participant is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range of intended use of anticoagulants.
✓. A male participant must agree to use contraception during the treatment period and plus an additional 90 days (a spermatogenesis cycle) for study treatments after the last dose of study treatment and refrain from donating sperm during this period; A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and plus 30 days (a menstruation cycle) for study treatments after the last dose of study treatment.
Exclusion criteria
✕. Small cell lung cancer (including mixed small cell and non-small cell lung cancer);
✕. Patients who have received systemic treatment for advanced/metastatic disease especially have received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g, CTLA-4, OX 40, CD137);
✕. Patients concurrently with 19del or 21L858R or other mutation types located in exon 18-21
✕. Patients who are known to have active brain metastases diagnosed by CT or MRI at the time of screening, however, participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without the requirement of steroid treatment for at least 14 days prior to the first dose of the study intervention.;
✕. Patients with severe and/or uncontrolled diseases, such as: