BI 2536 Second Line Monotherapy in SCLC

Study summary

Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBI 2536

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 22, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?10 U.S. locations

Locations may change over time.

Who runs it?Boehringer Ingelheim

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Boehringer Ingelheim
Interventions being studied: Drug: BI 2536

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Study topics

After prior treatment→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.

Reasons someone may not be able to joinExclusion criteria

More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
Symptomatic brain metastases or leptomeningeal disease
Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
Absolute neutrophil count (ANC) \<1,500/µl, platelet count \<100,000/µl, or hemoglobin \<9 mg/dl
Total bilirubin \>1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) \>2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) \>5 x ULN in case of known liver metastases, serum creatinine \>2.0 mg/dl (\>176 µmol/L, SI Unit equivalent)
Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug
Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug
Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection
Known or suspected active drug or alcohol abuse
Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug
Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®)
Patients with neuropathy (sensory or motor) CTCAE 3

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

1216.11.007 Boehringer Ingelheim Investigational SiteFayetteville, Arkansas
1216.11.003 Boehringer Ingelheim Investigational SiteChicago, Illinois
1216.11.006 Boehringer Ingelheim Investigational SiteEvanston, Illinois
1216.11.002 Boehringer Ingelheim Investigational SiteBoston, Massachusetts
1216.11.005 Boehringer Ingelheim Investigational SiteSt Louis, Missouri
1216.11.001 Boehringer Ingelheim Investigational SiteChapel Hill, North Carolina
1216.11.011 Boehringer Ingelheim Investigational SiteCharleston, South Carolina
1216.11.010 Boehringer Ingelheim Investigational SiteGreenville, South Carolina
1216.11.012 Boehringer Ingelheim Investigational SiteSeattle, Washington
1216.11.009 Alberta Cancer BoardEdmonton, Alberta

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 22, 2022. Always confirm current availability with the study team.

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