18 and older, any sex, with Small Cell Lung Cancer or Extensive-stage Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS)Primary· Time of treatment start until the criteria for disease progression or death. Up to a maximum of 7 months.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. PFS is defined as time from registration until disease progression met by RECIST 1.1 or death from any cause.
Group
Value
95% CI
Guadecitabine and Carboplatin (Platinum Sensitive)
1.9
1.2 – 2.5
Guadecitabine and Carboplatin (Platinum Resistant)
1.7
0.9 – 4.1
Adverse EventsSecondary· AEs had been recorded from time of signed informed consent until 30 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 5 months
All adverse events (AEs) had been determined according to the NCI Common Terminology Criteria for (NCI CTCAE) V5. A summary of the total number of participants is provided.
Group
Value
95% CI
Guadecitabine and Carboplatin
24
Objective Response Rate (ORR)Secondary· Up to a maximum of 7 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
ORR is defined as the proportion of all subjects with confirmed PR or CR according to RECIST 1.1
Group
Value
95% CI
Guadecitabine and Carboplatin (Platinum Sensitive)
7.1
0.2 – 33.9
Guadecitabine and Carboplatin (Platinum Resistant)
0
NA – NA
Disease Control Rate (DCR)Secondary· Up to a maximum of 7 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD.
DCR defined as CR + PR + Stable Disease (SD) \>=8 weeks per RECIST 1.1
Group
Value
95% CI
Guadecitabine and Carboplatin (Platinum Sensitive)
42.9
17.7 – 71.1
Guadecitabine and Carboplatin (Platinum Resistant)
33.3
7.5 – 70.1
Overall Survival (OS)Secondary· Time of treatment start until death or date of last contact, up to a maximum of 16 months.
Overall survival is defined as the time from treatment start until death or date of last contact.
Group
Value
95% CI
Guadecitabine and Carboplatin (Platinum Sensitive)
6.8
2.7 – 10
Guadecitabine and Carboplatin (Platinum Resistant)
4.4
1.4 – 11.4
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality was monitored up to a maximum of 16 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored for up to 5 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a phase II, open-label, single arm, single-stage study. Both, chemo-sensitive and chemo-resistant patients will be enrolled and treated with 4 cycles of combination of Guadecitabine and carboplatin
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04340843 — Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metas
· Phase 2
· active not recruiting
NCT03576963 — Guadecitabine and Nivolumab in Treating Refractory Metastatic Colorectal Cancer
· Phase 1, PHASE2
· withdrawn
NCT03603964 — Guadecitabine Extension Study
· Phase 2
· terminated
NCT03257761 — Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer
· Phase 1
· active not recruiting
NCT03206047 — Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primar
· Phase 1, PHASE2
· completed
Other recruiting trials for Small Cell Lung Cancer
Currently open trials in the same condition.
NCT07476287 — Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult
· Phase 2
· recruiting
NCT07296809 — SKB500 Combinations in Patients With Small Cell Lung Cancer
· Phase 2
· recruiting
NCT07155200 — Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)
· Phase 1, PHASE2
· recruiting
NCT06922539 — ST-001 nanoFenretinide in Relapsed/ Refractory Small Cell Lung Cancer
· Phase 1
· recruiting
NCT07373964 — A Prospective, Single-Arm, Single-Center Phase II Study Evaluating the Efficacy and Safety of Chidamide Combined With PD
· Phase 2
· recruiting
Other Shadia Jalal, MD trials
Trials by the same sponsor.
NCT03840967 — A Study Evaluating Safety and Efficacy of Niraparib in Patients With Previously Treated Metastatic Esophageal/Gastroesop
· Phase 2
· terminated
NCT02639065 — A Study of Durvalumab (MEDI4736) in Esophageal Cancer
· Phase 2
· completed
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 Shadia Jalal, MD
Last refreshed: 20 December 2023
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/NCT03913455.