NCT03231475 (SPH1188-11) is a Phase 1 clinical trial of SPH1188-11 in NSCLC Stage IIIB, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd.

Who is sponsoring NCT03231475?

NCT03231475 is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd.

What drugs are being tested in NCT03231475?

Interventions in NCT03231475: SPH1188-11.

What condition does NCT03231475 study?

NCT03231475 studies NSCLC Stage IIIB, NSCLC Stage IV.

Is NCT03231475 still recruiting?

NCT03231475 is currently withdrawn. Last updated 8 November 2021.

Last reviewed 2021-11-08 · How we verify

NCT03231475: SPH1188-11

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase I Study of SPH1188-11 in NSCLC

Withdrawn Phase 1 Last updated 8 November 2021

What this trial tests

Phase 1 trial testing SPH1188-11 in NSCLC Stage IIIB. Withdrawn.

Timeline

21 July 2017

Primary endpoint
31 December 2020

31 March 2022

Quick facts

Lead sponsor	Shanghai Pharmaceuticals Holding Co., Ltd
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	21 July 2017
Primary completion	31 December 2020
Estimated completion	31 March 2022
Sites	1 location across China

Drugs / interventions tested

SPH1188-11 — full drug profile →

Conditions studied

NSCLC Stage IIIB — all drugs for NSCLC Stage IIIB →
NSCLC Stage IV — all drugs for NSCLC Stage IV →

Sponsor

Shanghai Pharmaceuticals Holding Co., Ltd — full company profile →

Who can join

Adults 18 to 70, any sex, with NSCLC Stage IIIB or NSCLC Stage IV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Emerging therapeutic agents for advanced non-small cell lung cancer.
Chen R, Manochakian R, James L, Azzouqa AG, et al · · 2020 · cited 244× · PMID 32448366 · DOI 10.1186/s13045-020-00881-7

Verify or expand the search:

Other recruiting trials for NSCLC Stage IIIB

Currently open trials in the same condition.

NCT05816499 — Cadonilimab in Patients (Pts) With Advanced Non-small Cell Lung Cancer (NSCLC) · Phase 1, PHASE2 · active not recruiting
NCT04865250 — Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC · Phase 2 · recruiting
NCT04223596 — Clinical Utility of Liquid Biopsy in Brigatinib ALK+ Patients · Phase 2 · active not recruiting
NCT04027647 — Phase 2 Study of Dacomitinib in NSCLC · Phase 2 · active not recruiting
NCT03620669 — 1st Line Durvalumab in PS 2 NSCLC Patients · Phase 2 · active not recruiting

Other Shanghai Pharmaceuticals Holding Co., Ltd trials

Trials by the same sponsor.

NCT06839131 — A Clinical Study of SPH9788 Tablets in Healthy Chinese Subjects. · Phase 1 · recruiting
NCT06487455 — A Clinical Study of SPH7485 Tablets in the Treatment of Advanced Solid Tumors. · Phase 1 · recruiting
NCT06434597 — A Clinical Study of SPH5030 Tablets in the Treatment of Her2-positive/Mutated Biliary Tract OR Colorectal Cancer Patient · Phase 2 · recruiting
NCT06483373 — A Clinical Study of SPH7854 Granules in Healthy Subjects. · EARLY_PHASE1 · recruiting
NCT05046314 — A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03231475 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shanghai Pharmaceuticals Holding Co., Ltd
Last refreshed: 8 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03231475.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing