Abstract 521P
Background
Extensive-stage small-cell lung cancer (ES-SCLC) is an aggressive tumor type with limited therapeutic options and poor prognosis. It is worthy to explore the new treatment pattern in consideration of the rapid disease progression. Therefore, this study aims to explore the effectiveness and safety of camrelizumab combined with chemotherapy and apatinib in the first-line treatment of ES-SCLC.
Methods
In this phase II study, 40 patients with pathological diagnosis of ES-SCLC and without receiving prior systemetic therapy are anticipated to be enrolled, and will be dosed camrelizumab (200 mg, q3w) combined with etoposide (80-100 mg/m2, q3w, 4-6 cycles) and platinum drugs (selected by the researcher according to the patients, q3w, 4-6 cycles), followed by maintenance with camrelizumab and apatinib (250 mg, qd). The primary endpoint is 6-month progress-free survival (6-month PFS) rate while the secondary endpoints are objective response rate (ORR), disease control rate (DCR), progression-free survival, overall survival and safety.
Results
Up to August 20, 2023, 24 patients with a median age of 59 years (ranged from 38 to 75 years) were enrolled. All patients were capable for efficacy analysis, of which 21 patients achieved partial response, 1 had stable disease and 2 progressive disease. The 6-month PFS rate in evaluable patients was 58.82% (10/17). The ORR and DCR were 87.50% and 91.67%, respectively. During the course of therapy, most common grade 3 or worse treatment-related adverse events were increased AST level (4.17%), increased ALT level (4.17%), increased γ-GT (4.17%), hypertension (4.17%) and hypetriglyceridemia (4.17%). Common grade 1-2 adverse reactions included nausea (66.67%), vomiting(66.67%), anemia(50.00%), increased γ-GT (20.83%) and proteinuria (20.83%). The treatment was well tolerated and no toxic death occurred. All the adverse events can be controlled and alleviated after symptomatic treatment.
Conclusions
The significant benefit and controllable security reflected by the camrelizumab in combination with chemotherapy and apatinib could support this combination as a new first-line treatment option for this population.
Clinical trial identification
ChiCTR2000035599.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
143P - Ablation combined with tislelizumab in treating hepatocellular carcinoma: A phase II trial
Presenter: Yangxun Pan
Session: Poster Display
Resources:
Abstract
144P - Integrated clinical and genomic models using machine-learning methods to predict the efficacy of paclitaxel-based chemotherapy in patients with advanced gastric cancer from K-MASTER project
Presenter: Jwa Hoon Kim
Session: Poster Display
Resources:
Abstract
145P - Tislelizumab (TIS) + chemotherapy (Chemo)/chemoradiotherapy (CRT) as neoadjuvant treatment for resectable esophageal squamous cell carcinoma (R-ESCC)
Presenter: Longqi Chen
Session: Poster Display
Resources:
Abstract
146P - Phase (ph) Ib results of bemarituzumab (BEMA) added to capecitabine/oxaliplatin (CAPOX) or S-1/oxaliplatin (SOX) with or without nivolumab (NIVO) for previously untreated advanced gastric/gastroesophageal junction cancer (G/GEJC): FORTITUDE-103 study
Presenter: Keun-Wook Lee
Session: Poster Display
Resources:
Abstract
147P - Four-year overall survival (OS) update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (uHCC)
Presenter: Stephen Chan
Session: Poster Display
Resources:
Abstract
148P - Safety and efficacy of atezolizumab (Atezo) + bevacizumab (Bev) in Japanese patients (pts) with unresectable hepatocellular carcinoma (uHCC): Preliminary analysis of a prospective, multicenter, observational study (ELIXIR)
Presenter: Teiji Kuzuya
Session: Poster Display
Resources:
Abstract
149P - A prospective observational study of MSI screening in unresectable chemotherapy-naïve advanced gastric cancer/gastroesophageal junction cancer: WJOG13320GPS
Presenter: Yukiya Narita
Session: Poster Display
Resources:
Abstract
150P - Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Updated results from a multi-cohort, multi-center phase II trial ALTER-G-001-cohort C
Presenter: Junwei Wu
Session: Poster Display
Resources:
Abstract
151P - Relationship between depth of response and early tumor shrinkage with overall survival in advanced pancreatic cancer
Presenter: EMIKA KUROKI
Session: Poster Display
Resources:
Abstract
152P - Interim analysis of the NAPOLEON-2 study: Safety evaluation of nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer patients with prior biliary drainage
Presenter: Futa Koga
Session: Poster Display
Resources:
Abstract