Clinical trial NCT05055167: Envafolimab as First-line Treatment of Aged Patients in Advanced NSCLC
Official title: A Phase II Study of Envafolimab as First-line Treatment of Aged Patients With High PD-L1 Expression Stage in Advanced Non-small-cell Lung Cancer(NSCLC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Stage IV
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2021-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Explore the efficacy and safety of Envafolimab in first line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer with high PD-L1 expression, view to providing better treatment options for elderly patients with high PD-L1 expression and improving the survival and prognosis of patients .


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent.
* Age strictly at least 70 years.
* Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma, large-cell carcinoma) of locally advanced (stage IIIb/IIIc), metastatic, or relapsing (stage IV) according to the American Joint Committee on Cancer Staging Handbook.
* Presence of at least one measurable target lesion (RECIST rules) in a non irradiated region.
* No previous systemic chemotherapy for lung cancer.
* PD-L1≥50% in tissue samples detected by immunohistochemistry.
* PS 0 or 1.
* Life expectancy sup 12 weeks.
* Normal hematologic function.

Exclusion Criteria:

* EGFR-sensitive mutations or ALK rearrangements
* Previous treatment with immune checkpoint inhibitors
* Presence of symptomatic brain metastases；
* Chinese patent medicine with anti-lung cancer indications or immunoregulatory drugs (including thymopeptide, interferon and interleukin, except for the local use of pleural effusion control) for systemic treatment；
* Another previous or concomitant cancer, except for basocellular cancer of the skin or treated cervical cancer in situ；
* Concurrent administration of one or several other antitumor therapies；
* Concurrent participation in another clinical trial；
* Active autoimmune disease requiring systemic treatment occurred within 2 years prior to initial；
* Systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to initial administration；
* Contraindication to the study drugs；
* Has not fully recovered from toxicity and/or complications caused by any intervention prior to the commencement of treatment (i.e., grade 1 or baseline, excluding fatigue or hair loss);
* A history of human immunodeficiency virus (HIV) infection;
* Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the research center);
* Active HCV infected;
* Recent vaccination within 30 days before the first administration (cycle 1, day 1);
* Other severe concurrent disorders that occurred during the prior six months before enrollment (myocardial infection, severe or unstable angor, NYHA class 3 or 4 congestive heart failure, transient or constituted cerebral ischemic attack, psychiatric or neurological disorders preventing the patient from understanding the trial, uncontrolled infections).

Primary outcomes:
measure: Objective Response Rate
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xiamen
country: China
facility: First affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References: