EGFR-TKIs Plus PD-1 in EGFR-Mutant Advanced NSCLC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanfang Hospital, Southern Medical University
About this trial
This study is an open-label, multicenter, single-arm clinical study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with histologically or cytologically confirmed, previously untreated EGFR-mutant (19del/L858R) locally advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC), according to the 9th edition of the TNM staging system for lung cancer jointly issued by the International Association for the Study of Lung Cancer (IASLC) and the American Joint Committee on Cancer (AJCC);
Male or female patients aged ≥ 18 years;
Patients who are willing to receive third-generation EGFR-TKI targeted therapy, followed by maintenance therapy with a PD-1 antibody during the stable phase of the disease (defined as no further tumor shrinkage for at least two consecutive assessments based on RECIST v1.1 criteria);
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Disqualifiers
Patients who are ineligible for standard anti-tumor therapy according to routine clinical practice;
Prior treatment with anti-PD-1/PD-L1 immunotherapy;
Concurrent enrollment in another clinical study;
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
Trial design
Design model
Single group
Treatments tested in this trial
EGFR-TKIs Combined with PD-1 Monoclonal Antibody
DrugEGFR-TKIs Combined with PD-1 Monoclonal Antibody
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: EGFR-TKIs Combined with PD-1 Monoclonal AntibodyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Median Progression-free survival
from randomization (or initiation of treatment) to the first occurrence of disease progression or death from any cause.
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 monthsSecondary outcomes
1
objective response rate
The proportion of patients whose tumor volume reduction meets predefined criteria (Complete Response or Partial Response) and is maintained for a certain period of time.
Time frame
through study completion, an average of 3 years.2
Disease Control Rate
The DCR is the percentage of patients achieving CR, PR or SD per RECIST criteria at the first tumor assessment.
Time frame
through study completion, an average of 3 years.3
Median Overall Survival
the time from randomization (or initiation of treatment) at which 50% of patients have died.
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months4
The incidence and severity of treatment-related adverse events (AEs) and serious adverse events (SAEs) assessed according to NCI CTCAE v5.0, as well as laboratory abnormalities.
Adverse events were graded according to NCI CTCAE v5.0 and collected from the first dose to 30 days after the last dose. Serious adverse events were collected from the signing of informed consent through the end of the study.
Time frame
through study completion, an average of 3 years.Sponsors and contacts
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Source ClinicalTrials.gov