Dinutuximab and Irinotecan Versus Irinotecan to Treat Subjects With Relapsed or Refractory Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT03098030. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period \<3 months or ≥3 months).
Study identification
- NCT ID
- NCT03098030
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 483 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 1, 2017 (Actual)
- Primary completion
- Jan 27, 2020 (Actual)
- Completion
- Mar 26, 2020 (Actual)
- Last update posted
- Dec 9, 2020
2017 – 2020
United States locations
- U.S. sites
- 40
- U.S. states
- 24
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Clinical Research Center | Anchorage | Alaska | 99503 | — |
| Cancer Treatment Centers of America - Western Regional Medical Center | Goodyear | Arizona | 85338 | — |
| Innovative Clinical Research Institute | Tucson | Arizona | 85745 | — |
| Genesis Cancer Center | Hot Springs | Arkansas | 71913 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | — |
| Olive View - UCLA | Sylmar | California | 91342 | — |
| Innovative Clinical Research Institute | Whittier | California | 90603 | — |
| Hartford Hospital | Hartford | Connecticut | 06062 | — |
| Eastern Connecticut Hematology and Oncology Assoc | Norwich | Connecticut | 06360 | — |
| Alpha Oncology Research LLC | DeBary | Florida | 32713 | — |
| 21st Century Oncology | Jacksonville | Florida | 32204 | — |
| Comprehensive Hematology Oncology | St. Petersburg | Florida | 33709 | — |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | — |
| Northwest Georgia Oncology Centers, P.C. | Marietta | Georgia | 30060 | — |
| Baptist Health Floyd Cancer Center | New Albany | Indiana | 47150 | — |
| Physicians' Clinic of Iowa Hematology and Oncology | Cedar Rapids | Iowa | 52403 | — |
| Kentucky Cancer Clinic | Hazard | Kentucky | 41701 | — |
| University of Kentucky | Lexington | Kentucky | 40506 | — |
| 21st Century Oncology | Louisville | Kentucky | 40215 | — |
| Cox Health Medical | Springfield | Missouri | 65807 | — |
| Billings Clinic Cancer Center | Billings | Montana | 59101 | — |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| The University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | — |
| UH Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cancer Treatment Centers of America at Southwestern RMC | Tulsa | Oklahoma | 74133 | — |
| Kaiser Permanente Northwest Center for Health Research CRSS | Portland | Oregon | 97227 | — |
| Fox Chase Cancer Center Office of Clinical Research | Philadelphia | Pennsylvania | 19111 | — |
| Cancer Treatment Centers of America at Eastern Regional Medical Center | Philadelphia | Pennsylvania | 19124 | — |
| Charleston Oncology | Charleston | South Carolina | 29414 | — |
| Spartanburg Medical Center/Gibbs Cancer Center and Research Institute | Spartanburg | South Carolina | 29303 | — |
| Prairie Lakes Health Care | Watertown | South Dakota | 57201 | — |
| Center for Biomedical Research | Knoxville | Tennessee | 37909 | — |
| Texas Health Physicians Group | Arlington | Texas | 76012 | — |
| Plano Cancer Institute | Plano | Texas | 75093 | — |
| The University of Texas Health Science Center at Tyler, Office of Clinical Studies | Tyler | Texas | 75701 | — |
| Vista Oncology (Shelton office) | Shelton | Washington | 98584 | — |
| United Hospital Center | Bridgeport | West Virginia | 26330 | — |
| Camden Clark Medical Center / Regional Cancer Center | Parkersburg | West Virginia | 26101 | — |
| University of Wisoncsin - Carbone Cancer Ctr | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 186 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03098030, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 9, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03098030 live on ClinicalTrials.gov.