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Blood Draw Research Program for Lung Cancer (PCG Trial)
Phase 4
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
PCG Trial Summary
This trial will study how well a scalable, prospective research program works for people with metastatic non-small cell lung cancer or extensive-stage small-cell lung cancer who are starting standard-of-care systemic anti-cancer treatment.
Who is the study for?
This trial is for people with advanced lung cancer, either metastatic non-small cell (mNSCLC) or extensive-stage small-cell (ES-SCLC), who are about to start standard treatments. They must have a confirmed diagnosis and, if in the front-line immunotherapy group, should have received certain immune-blocking drugs under another protocol.Check my eligibility
What is being tested?
The study aims to test how feasible it is to run a large-scale research program that tracks patients' responses to standard cancer treatments over time by looking at changes in ctDNA—a marker of cancer—in their blood.See study design
What are the potential side effects?
Since this trial involves only blood draws and no new medications are being tested directly within this study, side effects would be minimal—primarily related to the blood draw procedure itself such as bruising or fainting.
PCG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Enrolled Participants Submitting Sufficient Blood Samples
Proportion of Potential Eligible Participant Enrollment
Secondary outcome measures
Blood Level of ctDNA
Side effects data
From 2017 Phase 2 trial • 14 Patients • NCT0143748864%
Fatigue
43%
Diarrhea
36%
Constipation
36%
Anemia
36%
Nausea
21%
Creatinine Increased
21%
Lightheadedness
21%
Vomiting
21%
Hypokalemia
14%
Abdominal Pain
14%
Back Pain
14%
Dizziness
14%
Fever
14%
Flu-Like symptoms
14%
Hypomagnesia
14%
Pinching sensation around port
14%
Shortness of Breath
14%
URI
14%
Abdominal cramping
14%
Insomnia
14%
Thrombocytopenia
7%
Tinnitus
7%
Sacral Edema
7%
Dry Skin
7%
Decreased Appetite
7%
Blood in Bilirubin increased
7%
Bloating
7%
Tearing
7%
Acid Reflux
7%
INR increased
7%
Embolic stroke
7%
Pulmonary Embolism
7%
Anorexia
7%
Anxiety
7%
Dyspnea
7%
Dysuria
7%
Fall
7%
Flatulence
7%
Foot Pain
7%
Hematoma
7%
Leg pain
7%
Loose Stools
7%
mild-mod Congestion
7%
Neutrophil count decreased
7%
Neuropathy
7%
Rib pain
7%
Throat discomfort
7%
Urinary incontinence
7%
Urinary Tract Obstruction
7%
Worsening pain
7%
Vision changes
7%
Hypoxia
7%
Abdominal distention
7%
Alkalosis
7%
Bladder Spasm
7%
Blurred Vision
7%
Bone Pain
7%
Cabazitaxel Infusion reaction
7%
Change in Taste
7%
Epigastric Pain
7%
Hematuria
7%
Hypophosphatemia
7%
Hypertension
7%
Pain in Pelvis
7%
Paresthesia bilateral feet
7%
Perioral numbness
7%
Peripheral Neuropathy
7%
Weakness
7%
Weight loss
7%
Tachycardia
7%
Bleeding Gums
7%
PTT prolonged
7%
Pyelonephritis
7%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabazitaxel
PCG Trial Design
2Treatment groups
Experimental Treatment
Group I: Front-line Immunotherapy Re-enrollment CohortExperimental Treatment1 Intervention
Participants with mNSCLC or ES-SCLC that have received front-line treatment as defined by the protocol will give blood samples at three separate timepoints for ctDNA profiling.
Group II: All-Comer CohortExperimental Treatment1 Intervention
Participants with mNSCLC or ES-SCLC will give blood samples at three separate timepoints for ctDNA profiling.
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,541 Previous Clinical Trials
567,108 Total Patients Enrolled
Flatiron Health, Inc.; Foundation Medicine, Inc.UNKNOWN
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
887,969 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are planning to start standard anti-cancer treatment.You have been diagnosed with advanced or metastatic lung cancer.You have already received a specific type of immunotherapy as your first treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Front-line Immunotherapy Re-enrollment Cohort
- Group 2: All-Comer Cohort
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized Blood Draw as a safe procedure?
"With this treatment having been approved, the safety rating for Blood Draw is a 3 on our team's scale."
Answered by AI
How many healthcare centers in the state are running this experiment?
"This clinical trial is recruiting participants from 15 different medical sites. Among them are University Cancer & Blood Center, LLC; Research in Athens, Piedmont Cancer Institute, PC in Atlanta and Ironwood Cancer & Research Centers in Chandler."
Answered by AI
Is this clinical research actively seeking participants?
"As reflected on clinicaltrials.gov, this particular medical trial is not presently open to enrollment. The research project was first posted in December of 2019 and the last update came at the end of October 2022. Although no longer recruiting patients, 1851 other studies are actively taking partcipants currently."
Answered by AI
Who else is applying?
What site did they apply to?
SCRI Florida Cancer Specialists PAN
What portion of applicants met pre-screening criteria?
Met criteria
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