Active not recruiting

A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

I3Y-MC-JPCE - ClinicalTrials.gov - NCT02779751

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.
How long will I be in the trial?
Your participation could last up to 6 months depending on how you and your tumor respond.
Email
Active not recruiting

A Study of Abemaciclib (LY2835219) in Participants With Non-Small Cell Lung Cancer or Breast Cancer

I3Y-MC-JPCE - ClinicalTrials.gov - NCT02779751

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.
How long will I be in the trial?
Your participation could last up to 6 months depending on how you and your tumor respond.
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have a Stage IV diagnosis of one of the following: KRAS mt, PD-L1+ NSCLC, squamous NSCLC or HR+, HER2, Metastatic breast cancer

Participant must be willing and able to provide tumor tissue both prior to treatment and after treatment initiation

Participant must have discontinued all previous treatments for cancer and recovered from the acute effects of therapy

Participants must NOT

Participant must not have a history of interstitial lung disease or pneumonitis

Participant must not have a history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years

Participant must not have received a live vaccination within 30 days of study start

Participant must not have received prior treatment with an anti PD-1, anti-programmed death ligand 1 (PD-L1), or anti cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent

Trial Summary

Conditions the trial is for

Non-small Cell Lung Cancer, Breast Cancer

What the trial is testing?

Abemaciclib, Pembrolizumab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

November 2016 - October 2021

Trial Phase

1

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have a Stage IV diagnosis of one of the following: KRAS mt, PD-L1+ NSCLC, squamous NSCLC or HR+, HER2, Metastatic breast cancer

Participant must be willing and able to provide tumor tissue both prior to treatment and after treatment initiation

Participant must have discontinued all previous treatments for cancer and recovered from the acute effects of therapy

Participants must NOT

Participant must not have a history of interstitial lung disease or pneumonitis

Participant must not have a history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents for the past 2 years

Participant must not have received a live vaccination within 30 days of study start

Participant must not have received prior treatment with an anti PD-1, anti-programmed death ligand 1 (PD-L1), or anti cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent

Trial Summary

Conditions the trial is for

Non-small Cell Lung Cancer, Breast Cancer

What the trial is testing?

Abemaciclib, Pembrolizumab

Could I receive a Placebo?

no

Enrollment Goal

100

Trial Dates

November 2016 - October 2021

Trial Phase

1

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?