Asset profile

Serplulimab

Monoclonal antibody

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Reliablesignal

Evidence outlook · lead readout

NCT04033354 · Squamous Non Small Cell Lung Cancer

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

NCT04033354: In this randomized, double-blind, placebo-controlled Phase 3 trial of 537 patients with advanced squamous non-small-cell lung cancer, adding serplulimab to platinum-based chemotherapy significantly extended progression-free survival compared with chemotherapy plus placebo, and overall survival was also significantly improved at final analysis.

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Competitive landscape

83 competitors in this universe: 22 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 61 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Serplulimab: this drugPhase 3Monoclonal antibodyPD-1
CemiplimabApprovedMonoclonal antibodyPD-1
NivolumabApprovedMonoclonal antibodyPD-1
Opdivo QvantigApprovedMonoclonal antibodyPD-1
PembrolizumabApprovedMonoclonal antibodyPD-1
Pembrolizumab Berahyaluronidase AlfaApprovedMonoclonal antibodyPD-1
RetifanlimabApprovedMonoclonal antibodyPD-1
ToripalimabApprovedMonoclonal antibodyPD-1
Abp 234Phase 3Monoclonal antibodyPD-1
BalstilimabPhase 3Monoclonal antibodyPD-1
CamrelizumabPhase 3Monoclonal antibodyPD-1
CetrelimabPhase 3Monoclonal antibodyPD-1
CT-P51Phase 3Small moleculePD-1
DostarlimabPhase 3Monoclonal antibodyPD-1
EnlonstobartPhase 3Monoclonal antibodyPD-1
MB12Phase 3Monoclonal antibodyPD-1

…and 68 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(75 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (13)
October 2026 (4)
Phase 2SCLC, Extensive StageActive not recruiting
Est. primary completion 2026-10-22 · NCT06812260 · CT.gov ↗
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Phase 1/2Neuroendocrine CarcinomaRecruiting
Est. primary completion 2026-10-28 · NCT05747729 · CT.gov ↗
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Phase 1/2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2026-10-30 · NCT06848699 · CT.gov ↗
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Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2026-10-31 · NCT07647094 · CT.gov ↗
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December 2026 (9)
Phase 2Triple Negative Breast CancerRecruiting
Est. primary completion 2026-12 · NCT07283692 · CT.gov ↗
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Phase 2Extensive-Stage Small Cell Lung CancerRecruiting
Est. primary completion 2026-12 · NCT06497530 · CT.gov ↗
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Phase 1Tumor Associated Lymph Node T Cell, Advanced Solid Tumor, Immunotherapy, Serplulimab InjectionRecruiting
Est. primary completion 2026-12-19 · NCT06716619 · CT.gov ↗
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Phase 2Colorectal CancerRecruiting
Est. primary completion 2026-12-28 · NCT05954429 · CT.gov ↗
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Phase 2pMMR, MSS, MSI-L, Locally Advanced Rectal CarcinomaRecruiting
Est. primary completion 2026-12-30 · NCT05731726 · CT.gov ↗
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Phase 2Stage III Gastric CancerNot yet recruiting
Est. primary completion 2026-12-31 · NCT07391826 · CT.gov ↗
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Phase 2Malignant AscitesRecruiting
Est. primary completion 2026-12-31 · NCT06433869 · CT.gov ↗
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Phase 2HER2-positive Gastric CancerNot yet recruiting
Est. primary completion 2026-12-31 · NCT06439550 · CT.gov ↗
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Phase 2/3Colorectal Cancer, Liver MetastasesRecruiting
Est. primary completion 2026-12-31 · NCT06280495 · CT.gov ↗
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2027 (34)
January 2027 (3)
Phase 2Small Cell Lung CancerRecruiting
Est. primary completion 2027-01-25 · NCT06295926 · CT.gov ↗
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Phase 2Gastric Cancer Stage IIIActive not recruiting
Est. primary completion 2027-01-31 · NCT07257575 · CT.gov ↗
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Phase 4Colorectal Cancer (Locally Advanced or Metastatic), Colorectal Cancer Microsatellite Stable (MSS)Not yet recruiting
Est. primary completion 2027-01-31 · NCT07446465 · CT.gov ↗
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February 2027 (1)
Phase 2Carcinoma, HepatocellularRecruiting
Est. primary completion 2027-02-10 · NCT06349980 · CT.gov ↗
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April 2027 (1)
Phase 2Locally Advanced Pancreatic Ductal AdenocarcinomaRecruiting
Est. primary completion 2027-04-15 · NCT07101679 · CT.gov ↗
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May 2027 (3)
Phase 2Small-cell Lung CancerRecruiting
Est. primary completion 2027-05-01 · NCT07583511 · CT.gov ↗
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Phase 2Breast Cancer (Triple Negative Breast Cancer (TNBC))Not yet recruiting
Est. primary completion 2027-05-15 · NCT07487519 · CT.gov ↗
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Phase 2Esophageal Squamous Cell Carcinoma (ESCC)Not yet recruiting
Est. primary completion 2027-05-31 · NCT07403435 · CT.gov ↗
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June 2027 (4)
Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-06-18 · NCT07253142 · CT.gov ↗
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Phase 2Resectable Esophageal Squamous Cell CarcinomaRecruiting
Est. primary completion 2027-06-30 · NCT07457528 · CT.gov ↗
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Early phase / not applicableSmall Cell Lung CancerNot yet recruiting
Est. primary completion 2027-06-30 · NCT06462105 · CT.gov ↗
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Early phase / not applicableGastric CancerRecruiting
Est. primary completion 2027-06-30 · NCT06128252 · CT.gov ↗
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July 2027 (4)
Phase 2Urothelial Carcinoma, Biliary Tract Cancer, HER2Recruiting
Est. primary completion 2027-07 · NCT07506057 · CT.gov ↗
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Phase 3PDAC - Pancreatic Ductal AdenocarcinomaNot yet recruiting
Est. primary completion 2027-07 · NCT07336953 · CT.gov ↗
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Phase 1/2Colon Cancer AdenocarcinomaNot yet recruiting
Est. primary completion 2027-07-28 · NCT07358585 · CT.gov ↗
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Phase 3Locally Advanced Rectal Cancer (LARC), Immunotherapy, Radiotherapy, Total Neoadjuvant Therapy, Anal Function PreservationRecruiting
Est. primary completion 2027-07-31 · NCT07020247 · CT.gov ↗
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August 2027 (3)
Phase 2Metastatic Pancreatic Ductal AdenocarcinomaNot yet recruiting
Est. primary completion 2027-08-01 · NCT07733050 · CT.gov ↗
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Phase 2ESCC, Biliary Tract Cancer, Gastric Cancer, Pancreas CancerNot yet recruiting
Est. primary completion 2027-08-09 · NCT06531291 · CT.gov ↗
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Phase 2Locally Advanced Rectal Cancer, Neoadjuvant TherapyRecruiting
Est. primary completion 2027-08-31 · NCT07150949 · CT.gov ↗
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September 2027 (2)
Phase 2Small-Cell Carcinoma of the EsophagealNot yet recruiting
Est. primary completion 2027-09-01 · NCT07155122 · CT.gov ↗
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Phase 2Colorectal Cancer, RelapseRecruiting
Est. primary completion 2027-09-10 · NCT07604909 · CT.gov ↗
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October 2027 (2)
Phase 2/3Rectal CancerNot yet recruiting
Est. primary completion 2027-10 · NCT07134218 · CT.gov ↗
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Phase 2Non-clear Cell Renal Cell CarcinomaActive not recruiting
Est. primary completion 2027-10-22 · NCT05831891 · CT.gov ↗
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November 2027 (1)
Phase 2Cervical CancerRecruiting
Est. primary completion 2027-11-30 · NCT07340489 · CT.gov ↗
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December 2027 (10)
Phase 2Extensive Stage Lung Small Cell CancerNot yet recruiting
Est. primary completion 2027-12 · NCT07172412 · CT.gov ↗
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Phase 2Locally Advanced Rectal Cancer (LARC)Recruiting
Est. primary completion 2027-12-01 · NCT07347951 · CT.gov ↗
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Phase 2Metastatic Colorectal Cancer (CRC)Not yet recruiting
Est. primary completion 2027-12-15 · NCT07622550 · CT.gov ↗
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Phase 2Carcinoma of Head and/or NeckRecruiting
Est. primary completion 2027-12-30 · NCT06857279 · CT.gov ↗
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Phase 2Non-Small Cell Lung CancerRecruiting
Est. primary completion 2027-12-31 · NCT07398937 · CT.gov ↗
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Phase 2Newly Diagnosed MYC/BCL2 Double-expressor DLBCLActive not recruiting
Est. primary completion 2027-12-31 · NCT07538180 · CT.gov ↗
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Phase 2Locally Advanced Colorectal Cancer, Colorectal AdenocarcinomaNot yet recruiting
Est. primary completion 2027-12-31 · NCT07691632 · CT.gov ↗
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Phase 2Rare TumourNot yet recruiting
Est. primary completion 2027-12-31 · NCT06692491 · CT.gov ↗
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Phase 2Non-Clear Cell Renal Cell CarcinomaActive not recruiting
Est. primary completion 2027-12-31 · NCT07488533 · CT.gov ↗
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Phase 2Colorectal Carcinoma, Oligometastases, pMMR, MSS, iTNTRecruiting
Est. primary completion 2027-12-31 · NCT06850103 · CT.gov ↗
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2028 (20)
January 2028 (2)
Phase 3Rectal Cancer, Total Neoadjuvant Therapy, Radiotherapy, ImmunotherapyRecruiting
Est. primary completion 2028-01-01 · NCT07113275 · CT.gov ↗
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Phase 2Locally Advanced or Metastatic Solid Tumors, PTEN Loss or Low ExpressionNot yet recruiting
Est. primary completion 2028-01-09 · NCT07446049 · CT.gov ↗
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February 2028 (3)
Phase 2Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2028-02 · NCT07418866 · CT.gov ↗
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Phase 2Breast Cancer, Serplulimab Combined With SHR-A1811 as Neoadjuvant Therapy for Triple-Negative Breast CancerNot yet recruiting
Est. primary completion 2028-02-01 · NCT07466303 · CT.gov ↗
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Phase 2Rectal CancerNot yet recruiting
Est. primary completion 2028-02-01 · NCT07381400 · CT.gov ↗
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March 2028 (2)
Phase 2Unresectable Colon Cancer Peritoneal Metastases, PMMR/Ras/BRAF Wild-typeRecruiting
Est. primary completion 2028-03 · NCT05742425 · CT.gov ↗
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Phase 2HR+/HER2- Breast CancerRecruiting
Est. primary completion 2028-03-31 · NCT06860529 · CT.gov ↗
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May 2028 (1)
Phase 2Locally Advanced Gastric Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction AdenocarcinomaNot yet recruiting
Est. primary completion 2028-05-09 · NCT07621484 · CT.gov ↗
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June 2028 (1)
Early phase / not applicableLocally Advanced Proximal Gastric or Gastroesophageal Junction AdenocarcinomaNot yet recruiting
Est. primary completion 2028-06-30 · NCT07674342 · CT.gov ↗
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July 2028 (1)
Phase 2Rectal Cancer, Moderately Hypofractionated Radiotherapy, Serplulimab, pMMR/MSSNot yet recruiting
Est. primary completion 2028-07 · NCT07527520 · CT.gov ↗
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August 2028 (1)
Phase 2Colorectal Cancer (Diagnosis)Not yet recruiting
Est. primary completion 2028-08-31 · NCT07134101 · CT.gov ↗
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September 2028 (3)
Phase 1/2Refractory Pancreatic Ductal Adenocarcinoma, Refractory Pancreatic AdenocarcinomaNot yet recruiting
Est. primary completion 2028-09-01 · NCT07175389 · CT.gov ↗
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Phase 2Gastric Cancer Peritoneal Metastasis (GCPM)Not yet recruiting
Est. primary completion 2028-09-01 · NCT07784413 · CT.gov ↗
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Early phase / not applicableNon-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2028-09-01 · NCT06580665 · CT.gov ↗
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November 2028 (1)
Phase 2Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) AdenocarcinomaRecruiting
Est. primary completion 2028-11-30 · NCT07699939 · CT.gov ↗
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December 2028 (5)
Phase 1Small Cell Lung CancerRecruiting
Est. primary completion 2028-12 · NCT07231445 · CT.gov ↗
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Phase 3Locally Advanced Low Rectal Adenocarcinoma, pMMR (Microsatellite Stable Rectal Cancer)Not yet recruiting
Est. primary completion 2028-12-29 · NCT07277842 · CT.gov ↗
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Phase 1/2NF2-related Schwannomatosis, NF2, Neurofibromatosis Type 2, Vestibular Schwannoma, MeningiomaNot yet recruiting
Est. primary completion 2028-12-31 · NCT07708285 · CT.gov ↗
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Phase 2Rectal Neoplasms, Rectal AdenocarcinomaNot yet recruiting
Est. primary completion 2028-12-31 · NCT07543848 · CT.gov ↗
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Phase 2pMMR/MSS, Locally Advanced Rectal Carcinoma, Fasting, IntermittentNot yet recruiting
Est. primary completion 2028-12-31 · NCT07779694 · CT.gov ↗
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2029 (3)
June 2029 (1)
Phase 3SCLC, Extensive StageRecruiting
Est. primary completion 2029-06 · NCT07739758 · CT.gov ↗
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July 2029 (1)
Phase 3Non-Resectable Pancreas CarcinomaRecruiting
Est. primary completion 2029-07-01 · NCT07235930 · CT.gov ↗
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December 2029 (1)
Phase 2ctDNA, Gastric Cancer, Gastroesophageal Junction (GEJ) Adenocarcinoma, Adjuvant TreatmentNot yet recruiting
Est. primary completion 2029-12-31 · NCT07507916 · CT.gov ↗
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2030 (1)
June 2030 (1)
Phase 1/2SCLC, Extensive StageNot yet recruiting
Est. primary completion 2030-06-30 · NCT07141771 · CT.gov ↗
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2031 (2)
January 2031 (1)
Phase 2/3Non-Small Cell Lung CancerNot yet recruiting
Est. primary completion 2031-01 · NCT07318883 · CT.gov ↗
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December 2031 (1)
Phase 2Gastric or Gastroesophageal Junction AdenocarcinomaNot yet recruiting
Est. primary completion 2031-12-31 · NCT07772557 · CT.gov ↗
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2035 (1)
December 2035 (1)
Phase 3Locally Advanced Nasopharyngeal CarcinomaRecruiting
Est. primary completion 2035-12-31 · NCT07177443 · CT.gov ↗
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2036 (1)
June 2036 (1)
Phase 2Neurofibromatosis Type 2, Vestibular Schwannoma, Non-vestibular Schwannoma, Meningioma, Ependymoma, NF2-related Schwannomatosis, NF2Not yet recruiting
Est. primary completion 2036-06-01 · NCT07713745 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (17)
Phase 2/3 (5)
Phase 2 (112)
Phase 1/2 (8)
Phase 1 (9)
Phase 4 (2)
Early phase / not applicable (7)
Appears in other studies (3)