Trial Title:
A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer
NCT ID:
NCT05566041
Condition:
Carcinoma, Small Cell Lung
Conditions: Official terms:
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Carboplatin
Etoposide
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
In this study, patients will be randomized to 1 of 2 groups or arms. Patients in Arm 1
will receive the study drug, RRx-001, once a week for 3 weeks followed by up to 4 cycles
of platinum doublet (platinum plus etoposide) chemotherapy. Patients with stable disease
or better will go on to the Platinum Stacking Phase and will receive RRx-001 once a week
for 2 weeks followed by 2 cycles of single agent platinum chemotherapy in a repeating
pattern until such time as their cancer gets worse.. Patients in Arm 2 will receive the
standard of care platinum doublet (platinum plus etoposide) chemotherapy for up to 4
cycles. . Patients in arm 2 whose cancer gets worse (as determined by imaging scans), may
"cross-over" to the Platinum Stacking Phase of Arm 1 (see study schema below).
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RRx-001 + eLOOP Device
Description:
RRx-001 is a small molecule anticancer drug which is mixed with patient's own blood using
the eLOOP device
Drug: Cisplatin/carboplatin plus etoposide Standard of care platinum doublet chemotherapy
Arm group label:
Arm 1
Intervention type:
Drug
Intervention name:
Cisplatin/carboplatin plus etoposide
Description:
Standard of care platinum doublet chemotherapy
Arm group label:
Arm 2
Summary:
This Global Phase 3 study aims to find out whether RRx-001 + platinum chemotherapy is
more effective than platinum chemotherapy alone in 3rd line or beyond small cell cancer.
Detailed description:
Small cell cancer (SCC), which mostly arises in the lungs but also in other parts of the
body as well such as the prostate and the intestines, is one of the most aggressive forms
of cancer; in fact, SCC is so aggressive that in 2012 Congress designated it a
recalcitrant or difficult-to-treat cancer, along with pancreatic cancer and glioblastoma
or GBM, a primary tumor of the brain, which share the terrible "distinction" of having a
5 year survival rate less than 50%.
One of the main reasons that SCC is so recalcitrant or difficult-to-treat has to do with
the development of resistance. Almost all cancers (and SCC is no exception) are treated
according to lines of therapy. A line of therapy is a particular course of treatment or
treatment regimen. So, in SCC, the first line of treatment is a platinum doublet, with
the word doublet meaning two, and consists of the double chemotherapy regimen of
cisplatin or carboplatin + etoposide. Most patients initially respond well to the
platinum doublet but unavoidably, as a matter of course, resistance to treatment develops
and, with that development, a new treatment in second line is started. The same pattern
is followed in later lines of therapy: resistance in second line leads to the start of
another treatment in 3rd line, and with resistance in 3rd line, which is, unfortunately,
just as inevitable, and usually happens even sooner, since the later the line of therapy
the more aggressive the tumor, a 4th line treatment is started and so on and so forth
until, eventually, no lines of treatment are left. The implicit or unwritten rule in
cancer therapy is that once resistance occurs on a particular treatment that same
treatment is never reintroduced or restarted.
RRx-001 is a form of immunotherapy that has the potential to overturn this unwritten rule
by sensitizing tumors, in other words, by making them more sensitive to the platinum
doublet that they received in first line. This is very important because, as previously
stated, the platinum doublet is usually the most effective therapy, so it is a benefit to
patients if sensitivity to the platinum doublet is restored or increased (even in cases
where no response ever occurred) and now they respond as if they were in 1st line rather
than in 3rd line or beyond.
In this study, which is called REPLATINUM, because patients will be reintroduced to or
restarted on a platinum doublet, there is a 50% chance of receiving either RRx-001 +
platinum doublet in Arm 1 or a platinum doublet without RRx-001 in Arm 2. However,
patients in arm 2 whose cancer progresses or gets worse (as determined by imaging scans),
have the opportunity to "cross-over" to Arm 1 and receive RRx-001 + platinum doublet
until such time as their cancer progresses. In this way, all patients, even those on Arm
2, are potentially eligible to be treated with RRx-001.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 and ≤ 80 years
2. Prior platinum treatment is required
3. Prior treatment with a checkpoint inhibitor is required unless contraindicated.
4. Patient must have received at least 2 prior lines of therapy
5. Biopsy confirmation of small cell lung cancer
6. Capable of providing informed consent and complying with trial procedures
7. Measurable disease by RECIST 1.1. Measurable lesions will be confirmed by imaging
(CT scan)
8. Performance Status (ECOG) 0-2
Exclusion Criteria:
1. Symptomatic central nervous system metastases or neurologically unstable patients
that are on increasing steroid dose.
2. The presence of another primary malignancy (excluding in situ of the cervix or basal
carcinoma of the skin)
3. Treatment of SCLC with any antineoplastic agent with the exception of steroids.
4. Patients with clinically significant illnesses which would compromise participation
in the study, including, but not limited to active or uncontrolled infection, immune
deficiencies, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled
hypertension, certain heart conditions, or mental illness/social situations that
would limit compliance with study requirements.
5. History of an allergic reaction to previously received platinum-based regimen, or
history of having to discontinue previously received platinum-based regimen
secondary to toxicity (excluding hematologic toxicity)
6. Any clinical laboratory findings, which give reasonable suspicion of a disease or
condition that contraindicates the use of any study medication or renders the
patient at high risk from treatment
7. Uncontrolled or symptomatic pleural or pericardial effusion
8. Pregnant or nursing. There is a potential for congenital abnormalities and for this
regimen to harm nursing infants
9. Virologic, serologic, or clinical evidence of active SARS-CoV-2 infection
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Address:
City:
Tampa
Zip:
33612
Country:
United States
Facility:
Name:
The University of Kansas Cancer Center
Address:
City:
Westwood
Zip:
66205
Country:
United States
Start date:
August 1, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
EpicentRx, Inc.
Agency class:
Industry
Collaborator:
Agency:
Sciclone Pharmaceuticals (China) Co., Ltd.
Agency class:
Other
Source:
EpicentRx, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566041
https://www.epicentrx.com/product-pipeline/
