Evidence map›Paper›PMID 38214075›Full record

Trial reportCancer medicine2024

A phase Ib study evaluating the safety and efficacy of IBI310 plus sintilimab in patients with advanced non-small-cell lung cancer who have progressed after anti-PD-1/L1 therapy.

Yuguang Zhao, Xiao Chen, Jun Yao, Jianlin Long, Yong Mao, Di Wu, Aimin Zang, Jun Zhao, Ziling Liu, Rui Meng and 5 more

Open access · goldAbstract readClinical Trial, Phase IComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 8 institutions in 2 countries.

Yuguang ZhaoThe First Hospital of Jilin University, Changchun, China.
Xiao ChenThe First Hospital of Jilin University, Changchun, China.
Jun YaoThe First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Jianlin LongChongqing University Affiliated Cancer Hospital, Chongqing, China.
Yong MaoAffiliated Hospital of Jiangnan University, Wuxi, China.
Di WuThe First Hospital of Jilin University, Changchun, China.
Aimin ZangAffiliated Hospital of Hebei University, Baoding, China.
Jun ZhaoBeijing Cancer Hospital, Beijing, China.ORCID 0000-0003-1464-7158
Ziling LiuThe First Hospital of Jilin University, Changchun, China.
Rui MengUnion Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Ye ChenInnovent Biologics, Inc., Suzhou, China.
Yang LuoInnovent Biologics, Inc., Suzhou, China.
Qun GuoInnovent Biologics, Inc., Suzhou, China.
Li LiInnovent Biologics, Inc., Suzhou, China.
Jiuwei CuiThe First Hospital of Jilin University, Changchun, China.ORCID 0000-0001-6496-7550
Jilin University · CNInnovative Biologics (United States) · USAffiliated Hospital of Hebei University · CNChongqing University · CNFirst Affiliated Hospital of Henan University of Science and Technology · CNPeking University · CNWuhan Union Hospital · CNWuxi Fourth People's Hospital · CN

Funding

Innovent Biologics
6 · The paper itself

Abstract

backgroundThe development of immune checkpoint inhibitors has made a significant breakthrough in the treatment of non-small-cell lung cancer (NSCLC). However, there remains a huge unmet clinical need for patients with acquired resistance after initial treatment response.

methodsThis study evaluated the combination of IBI310 (an anti-cytotoxic T lymphocyte-associated antigen-4 [CTLA-4] antibody) and sintilimab (an anti-programmed death 1 [PD-1]) antibody) in NSCLC patients who have previously been treated with anti-PD-1/ligand (L)1 and acquired resistance. The patients were randomly assigned to receive either a lower dose of IBI310 (1 mg/kg Q3W, cohort A) or a higher dose of IBI310 (3 mg/kg Q3W, cohort B) in combination with sintilimab (200 mg Q3W). The primary endpoints of the study were objective response rate (ORR) assessed by RECISTv1.1 and safety, while secondary endpoints included disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

resultsAs of November 2, 2023, the study had enrolled 30 patients, with 15 patients in each cohort. The ORR was 13.3% (2/15, 95% confidence interval [CI], 1.7-40.5) in cohort B. DCR were 46.7% (95% CI, 21.3-73.4) and 66.7% (95% CI, 38.4-88.2) in cohorts A and B, respectively. In cohorts A and B of this trial, the median follow-up times were 4.2 and 5.6 months, respectively. Median PFS was 1.45 (95% CI, 1.35-2.73) versus 2.73 (95% CI, 1.41-4.90) months for cohort A versus B; the median OS was 7.03 (95% CI, 3.09-not calculable [NC]) months in cohort A and 8.90 (95% CI, 5.13-NC) months in cohort B. Of the 30 patients, 86.7% in both cohorts experienced treatment-related adverse events (TRAEs) with Grade ≥3 TRAEs occurring in 40% and 53.3% of patients in cohorts A and B, respectively.

conclusionIBI310 3 mg/kg Q3W plus sintilimab was effective in a small number of previously treated anti-PD-1/L1-resistant NSCLC patients.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedHumansAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Agentssintilimab

Identifiers

PMID38214075
PMCPMC10905228
OpenAlexW4390789548

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.