25 Participants Needed

BIO 300 for Non-Small Cell Lung Cancer

Recruiting at 6 trial locations
NS
DG
Overseen ByDaniel Gomez, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study to find out whether giving BIO 300 in combination with thoracic radiation therapy is effective in preventing pneumonitis in people with non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD).

Who Is on the Research Team?

NS

Narek Shaverdian, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Stage I-II non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD). Participants need an ECOG performance status of 0-3, can give informed consent, and women must be post-menopausal or surgically sterile. A confirmed diagnosis of NSCLC is recommended but not mandatory if biopsy risks are too high.

Inclusion Criteria

My lung cancer is at an early stage (I or II).
I have lung disease confirmed by scans and breathing tests.
I am over 18 and can sign the consent form.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BIO 300 in combination with thoracic radiation therapy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

  • BIO 300

Trial Overview

The study tests BIO 300 combined with thoracic radiation therapy to see if it prevents pneumonitis in patients with NSCLC who also have ILD. The effectiveness of this combination treatment will be evaluated against the risk of developing pneumonitis.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with Non-Small Cell Lung Cancer and Interstitial Lung DiseaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+