---
title: Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Patients With Previously Untreated Extensive Stage Small-cell Lung Cancer
nct_id: NCT01987232
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Amgen
study_type: INTERVENTIONAL
primary_condition: Extensive-Stage Small-Cell Lung Cancer
countries: United States, Canada, Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01987232.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01987232"
ct_last_update_post_date: 2017-08-28
last_seen_at: "2026-05-12T07:25:10.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase 1b/2 Study of Carfilzomib, Carboplatin, and Etoposide in Patients With Previously Untreated Extensive Stage Small-cell Lung Cancer

**Official Title:** Phase 1b/2, Multicenter, Open-label Study of Carfilzomib, Carboplatin, and Etoposide in Subjects With Previously Untreated Extensive-stage Small-cell Lung Cancer

**NCT ID:** [NCT01987232](https://clinicaltrials.gov/study/NCT01987232)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 32
- **Lead Sponsor:** Amgen
- **Conditions:** Extensive-Stage Small-Cell Lung Cancer
- **Start Date:** 2013-11-05
- **Completion Date:** 2017-05-04
- **CT.gov Last Update:** 2017-08-28

## Brief Summary

The purpose of this study is to determine the maximum tolerated dose and assess the safety, tolerability and activity of carfilzomib given in combination with carboplatin and etoposide as initial therapy for patients with extensive-stage small-cell lung cancer (ES SCLC).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of extensive-stage small-cell lung cancer (ES-SCLC) with measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; ES-SCLC is defined as: small-cell lung cancer (SCLC) that has spread beyond one hemithorax and regional lymph nodes on the same side (e.g., supraclavicular) to the contralateral hemithorax, lymph nodes, or more distant locations in the body
2. Subjects with asymptomatic brain metastases or other central nervous system (CNS) disease at screening/diagnosis are eligible
3. Males and females ≥ 18 years of age
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Key Exclusion Criteria:

1. Previous systemic therapy to treat small-cell lung cancer (SCLC). Subjects with recurrent or progressive limited-stage SCLC after previous systemic treatment are not eligible for study participation.
2. Whole brain or focal radiation therapy within 14 days prior to Cycle 1 Day 1 (C1D1) for Phase 1b or prior to randomization for Phase 2
3. Congestive heart failure (New York Heart Association \[NYHA\] class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to prior to C1D1 for Phase 1b or prior to randomization for Phase 2
```

## Arms

- **Carfilzomib Combination** (EXPERIMENTAL) — Participants received carfilzomib on days 2, 3, 9, and 10 of each 21-day cycle as per the dose escalation schema, carboplatin at a target area under the curve (AUC) of 5 on day 1 of each cycle, and etoposide 100 mg/m² on days 1, 2, 3 of each 21-day cycle for up to 6 cycles. Participants with stable disease or better continued to receive carfilzomib alone until progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death, whichever occurred earliest.

## Interventions

- **Carfilzomib** (DRUG) — Administered by intravenous infusion.
- **Carboplatin** (DRUG) — Administered by intravenous infusion.
- **Etoposide** (DRUG) — Administered by intravenous infusion.

## Primary Outcomes

- **Number of Participants With Dose-limiting Toxicities** _(time frame: First 21-day Cycle)_ — The maximum tolerated dose (MTD) was defined as the highest dose level at which \< 33% of participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle. Dose-limiting toxicities were evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. A DLT was defined as:

* A grade 3 or greater non-hematologic toxicity that was assessed as related to carfilzomib by the investigator except in the case of neuropathy. A grade 2 or higher neuropathy with pain was considered a DLT.
* Grade 4 neutropenia: absolute neutrophil count (ANC) \< 500 mm³, lasting ≥ 7 days despite granulocyte colony stimulating factor support, or any febrile (temperature \> 38.3°C) neutropenia (ANC \< 1000 mm³).
* Thrombocytopenia of any grade associated with clinically significant bleeding or platelet/blood transfusion
* Grade 4 fatigue lasting ≥ 7 days
* Grade 3 nausea, vomiting or diarrhea lasting ≥ 7 days.

## Secondary Outcomes

- **Number of Participants With Adverse Events (AEs)** _(time frame: From first day of any study treatment (i.e., carfilzomib, carboplatin, or etoposide) up to 30 days after the last day of study treatment. The median overall duration of treatment was 16 weeks.)_
- **Overall Survival (OS) - Phase 2** _(time frame: 30 months)_
- **Maximum Plasma Concentration - Phase 2** _(time frame: Cycle 1 Day 2)_
- **Time of Maximum Plasma Concentration - Phase 2** _(time frame: Cycle 1 Day 2)_
- **Area Under Plasma Concentration-Time Curve - Phase 2** _(time frame: Cycle 1 Day 2)_

## Locations (17)

- Yale University, Yale Cancer Center, New Haven, Connecticut, United States
- UF Health Davis Cancer Pavilion and Shands Med Plaza, Gainesville, Florida, United States
- Goshen Center for Cancer Care, Goshen, Indiana, United States
- Horizon Oncology Research, Inc., Lafayette, Indiana, United States
- Indiana University Health Ball Memorial Hospital, Muncie, Indiana, United States
- Baptist Health Lexington Clinical Research Center, Lexington, Kentucky, United States
- Frederick Memorial Hospital, Frederick, Maryland, United States
- John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States
- Levine Cancer Institute, Charlotte, North Carolina, United States
- Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
- The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
- Juravinski Cancer Centre, Hamilton, Ontario, Canada
- Regional Budgetary Healthcare Institution "Kursk Regional Clinical Oncology Dispensary", Kislino, Kursk Oblast, Russia
- State budgetary healthcare institution of Arkhangelsk Region "Arkhangelsk Clinical Oncological Dispensary", Arkhangelsk, Russia
- Federal State Budgetary Scientific Institution "N.N. Blokhin Russian Cancer Research Center", Moscow, Russia
- State Budgetary Educational Inslitution of Higher Professional Education "First St. Petersburg I.P.Pavlov State Medical University", Saint Petersburg, Russia
- State Budgetary Healthcare Institution of Yaroslavl Region "Regional Clinical Oncological Hospital", Yaroslavl, Russia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.yale university, yale cancer center|new haven|connecticut|united states` — added _(2026-05-12)_
- `locations.uf health davis cancer pavilion and shands med plaza|gainesville|florida|united states` — added _(2026-05-12)_
- `locations.goshen center for cancer care|goshen|indiana|united states` — added _(2026-05-12)_
- `locations.horizon oncology research, inc.|lafayette|indiana|united states` — added _(2026-05-12)_
- `locations.indiana university health ball memorial hospital|muncie|indiana|united states` — added _(2026-05-12)_
- `locations.baptist health lexington clinical research center|lexington|kentucky|united states` — added _(2026-05-12)_
- `locations.frederick memorial hospital|frederick|maryland|united states` — added _(2026-05-12)_
- `locations.john theurer cancer center at hackensack umc|hackensack|new jersey|united states` — added _(2026-05-12)_
- `locations.levine cancer institute|charlotte|north carolina|united states` — added _(2026-05-12)_
- `locations.wake forest baptist health|winston-salem|north carolina|united states` — added _(2026-05-12)_
- `locations.the university of texas md anderson cancer center|houston|texas|united states` — added _(2026-05-12)_
- `locations.juravinski cancer centre|hamilton|ontario|canada` — added _(2026-05-12)_
- `locations.regional budgetary healthcare institution "kursk regional clinical oncology dispensary"|kislino|kursk oblast|russia` — added _(2026-05-12)_
- `locations.state budgetary healthcare institution of arkhangelsk region "arkhangelsk clinical oncological dispensary"|arkhangelsk||russia` — added _(2026-05-12)_
- `locations.federal state budgetary scientific institution "n.n. blokhin russian cancer research center"|moscow||russia` — added _(2026-05-12)_
- `locations.state budgetary educational inslitution of higher professional education "first st. petersburg i.p.pavlov state medical university"|saint petersburg||russia` — added _(2026-05-12)_
- `locations.state budgetary healthcare institution of yaroslavl region "regional clinical oncological hospital"|yaroslavl||russia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01987232.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01987232*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*