Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma

Sponsor
Hunan Cancer Hospital
Study ID
NCT04459078
Phase
PHASE2
Status
Unknown

Conditions

  • Adenocarcinoma of the Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Intravenous administration of (200mg/3weeks)
  • Albumin Paclitacxel — DRUG
    intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles)
  • Apatinib — DRUG
    Patients will be given oral of Apatinib (250mg Qd po for 5 days, take rest for 2 days every week)

Study Details

This study is a single arm, open label, national multicenter study, to explore the efficacy and safety of the combination of Camrelizumab, apatinib and albumin paclitaxel in advanced untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma. The study does not consider PD-L1 expression, but tumor samples need to be explored by PD-L1 detection and other exploratory analysis.

Key Dates

Start date
Aug 26, 2020
Status verified
Nov 2022
Primary completion
May 15, 2023
Completion
Jul 15, 2023

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab combined with Albumin Paclitacxel and Apatinib.
    Participants are given intravenous administration of Camrelizumab (200mg/3w) in addition with intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles) and Apatinib (250mg Qd po for 5 days,, take rest for 2 days every week). Treatment terminates when disease progression, death or unacceptable toxicity.

Primary Outcome Measure

PFS [ Time Frame: Up to 24 months ]