ONC-392 vs Chemotherapy for Lung Cancer
(PRESERVE-003 Trial)
Recruiting in Palo Alto (17 mi)
+242 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: OncoC4, Inc.
Must not be taking: Systemic steroids
Disqualifiers: Symptomatic brain metastasis, Active infections, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing gotistobart, a new drug that helps the immune system fight advanced lung cancer in patients who haven't responded to other treatments. It works by blocking a protein that allows cancer cells to hide from the immune system.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on systemic steroid therapy with more than 10 mg/day prednisone or equivalent within 7 days before starting the study treatment.
What data supports the effectiveness of the drug Gotistobart for lung cancer?
Research shows that docetaxel, a component of Gotistobart, is effective in treating advanced non-small cell lung cancer, improving survival and quality of life for patients who have not responded to other chemotherapy treatments.
12345Is Gotistobart (Docetaxel) generally safe for humans?
Docetaxel, also known as Gotistobart, has been used in various cancer treatments and is generally considered safe, though it can cause side effects like neutropenia (low white blood cell count) and fluid retention. These side effects are usually manageable with medications and monitoring.
678910What makes the drug Gotistobart (Docetaxel) unique for lung cancer treatment?
Gotistobart, also known as Docetaxel, is unique because it is a semisynthetic taxane that has shown effectiveness in treating advanced non-small cell lung cancer, both as a single agent and in combination with other therapies. It is particularly noted for its ability to improve quality of life and modestly extend survival in patients who have not responded to other chemotherapy treatments.
1231112Eligibility Criteria
This trial is for adults with metastatic non-small cell lung cancer (NSCLC) who have already tried PD-1/PD-L1 inhibitors and chemotherapy. Patients whose disease has worsened after treatment are eligible to participate.Inclusion Criteria
Histologically- or cytologically- confirmed diagnosis of metastatic NSCLC, metastasis can be regional lymph nodes or distant organs
My cancer has worsened after my last treatment.
At least 12 weeks of PD-1/PD-L1 inhibitor in combination with platinum-based chemotherapy
+7 more
Exclusion Criteria
Active GI disease, including peptic ulcer disease,
pancreatitis, diverticulitis, or inflammatory bowel
disease.
I last received anti-PD-1/PD-L1 treatment less than 28 days ago.
I have not taken more than 10 mg/day of steroids like prednisone in the last week.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment Stage I
Dose-confirmation stage assessing efficacy and safety of two gotistobart dosing regimens compared to docetaxel
21 weeks
1 visit every 3 weeks (in-person)
Treatment Stage II
Assessment of safety and efficacy of selected gotistobart dosing regimen versus docetaxel
21 weeks
1 visit every 3 weeks (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
36 months
Participant Groups
The study compares ONC-392, a new anti-CTLA-4 antibody, against docetaxel, a chemotherapy drug. The purpose of this study is to determine whether the study drug, ONC-392, is safe and well tolerated. The study will also test whether ONC-392 is effective in treating non-small call lung cancer, in comparison with the chemotherapy standard of care drug, docetaxel.
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Gotistobart 3 mg/kg Q3WExperimental Treatment1 Intervention
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Group II: Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3WExperimental Treatment1 Intervention
Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Group III: Arm 3: Docetaxel 75 mg/m2, Q3WActive Control1 Intervention
Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days.
Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇪🇺 Approved in European Union as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇨🇦 Approved in Canada as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
🇯🇵 Approved in Japan as Taxotere for:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Virginia Cancer Specialists, PCIrving, TX
XCancer/Dothan Hematology & OncologyDothan, AL
St. Joseph Hospital OrangeOrange, CA
Norton Cancer InstituteLouisville, KY
More Trial Locations
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Who Is Running the Clinical Trial?
OncoC4, Inc.Lead Sponsor
BioNTech SEIndustry Sponsor
References
Single-agent docetaxel (Taxotere) in the treatment of advanced non small-cell lung cancer: clinical concepts and commentary. [2019]Chemotherapy in recurrent or metastatic non small-cell lung cancer (NSCLC) has been shown to im-prove quality of life, and to provide a modest prolongation of survival. Docetaxel is a semisynthetic taxane that is an active agent for the treatment of NSCLC, both in previously untreated patients as well as those who have relapsed or progressed following cisplatin-based chemotherapy. After encouraging results in phase II studies, randomized trials have shown that treatment with single-agent docetaxel is superior to best supportive care for advanced NSCLC in both untreated and previously treated patients. This article will review the published data on the use of single-agent docetaxel in the treatment of advanced NSCLC.
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: an international update. [2019]Based on the results of two recent trials, docetaxel (Taxotere; Aventis, Antony, France) is now the drug of choice for the treatment of advanced non-small cell lung cancer that is refractory to primary chemotherapy. Trials are testing the role of docetaxel in the induction setting, as well as concomitantly with radiation therapy.
Docetaxel (Taxotere) in the treatment of non-small cell lung cancer: An international update. [2019]Based on the results of two recent trials, docetaxel (Taxotere; Aventis, Antony, France) is now the drug of choice for the treatment of advanced non-small cell lung cancer that is refractory to primary chemotherapy. Trials are testing the role of docetaxel in the induction setting, as well as concomitantly with radiation therapy.
Taxanes for advanced non-small cell lung cancer. [2019]The emergence of novel chemotherapeutic agents with promising anticancer activity in non-small cell lung cancer (NSCLC) during the 1990s has led to an expanded role for chemotherapy in the management of this disease. The taxanes (paclitaxel and docetaxel) are novel microtubule stabilising agents, and have become an integral part of several commonly-used chemotherapy regimens in NSCLC. Taxanes inhibit the growth of lung cancer cell lines, exhibit synergistic interaction with other chemotherapy agents and enhance the efficacy of radiation in vitro. When used in low doses (metronomic dosing), they have important antiangiogenic properties. Several Phase II and III clinical trials have established the efficacy of the taxanes, as single agents and when used in combination with a platinum compound, in the treatment of advanced NSCLC. The use of a taxane in combination with a platinum compound has become an acceptable standard for patients with advanced or metastatic NSCLC. In addition to its efficacy in the first-line therapy of NSCLC, docetaxel is also the FDA-approved second-line agent for recurrent or relapsed NSCLC in the US. Several ongoing trials are comparing the efficacy of combining molecularly targeted agents with taxane-based regimens for the treatment of advanced NSCLC.
Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. [2023]To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life.
Summary of phase II data of docetaxel (Taxotere), an active agent in the first- and second-line treatment of advanced non-small cell lung cancer. [2018]Six phase II studies have been conducted in the United States and Europe using docetaxel (Taxotere; Rhone-Poulenc Rorer, Antony, France) for advanced non-small cell lung cancer. One hundred eighty chemotherapy-naive patients in four studies and 88 patients who failed prior platinum-containing chemotherapy in two studies were treated with docetaxel 75 to 100 mg/m2 intravenously over 1 hour every 3 weeks. Fifty-nine percent of patients had adenocarcinoma and 82% had stage IV disease. At a dose of 100 mg/m2, 30% of evaluable chemotherapy-naive patients (27% of the intent-to-treat population) and 20% of evaluable platinum-refractory/resistant patients (17% of the intent-to-treat population) achieved a partial response; projected median survival is 9 months in both studies. Neutropenia was the primary dose-limiting acute side effect. Fluid retention, which occurred in patients who received multiple courses of treatment, was common but rarely dose-limiting, and may be ameliorated with prophylactic corticosteroids. Other toxic effects were relatively mild. Docetaxel has significant activity against advanced non-small cell lung cancer, producing a major response in both chemotherapy-naive patients and patients who had failed prior platinum-containing chemotherapy.
Docetaxel in non-small cell lung cancer: a review. [2019]Docetaxel (Taxotere, Aventis Pharma), a semisynthetic taxane targeting the beta-subunit of tubulin, has broad spectrum anticancer activity including non-small cell lung cancer (NSCLC). It is synergistic with platinum and radiation in preclinical models and has been tested clinically in every stage of NSCLC. Docetaxel-platinum combinations have an efficacy comparable to other newer-agent platinum doublets as first-line therapy in advanced NSCLC, and has been approved for use in this setting. Docetaxel was initially approved for NSCLC in the second-line setting following two Phase III trials demonstrating improved survival and quality of life. Ongoing clinical trials are investigating how best to combine docetaxel with thoracic radiotherapy in locally advanced disease. Preliminary studies evaluating docetaxel in the pre-operative setting have also been completed. Ongoing studies are focused on confirming the results observed with consolidation docetaxel in locally advanced NSCLC (SWOG 9504) and docetaxel in combination with molecularly targeted agents. This paper will review the pharmacology, preclinical, clinical and pharmacoeconomic data supporting the use of docetaxel in the treatment NSCLC.
[Efficacy of docetaxel in non-small cell lung cancer patients previously treated with platinum-containing chemotherapy. French Group of Pneumo-Cancerology]. [2018]Determine the response to, and toxicity of docetaxel (Taxotere) in patients (pts) with inoperable non-small-cell lung cancer (NSCLC) previously treated with platinum-containing chemotherapy.
A multicenter phase II study of docetaxel and carboplatin combination as front-line treatment in advanced non-small cell lung cancer. [2018]To evaluate the efficacy and safety of docetaxel in combination with carboplatin as first-line treatment of patients with inoperable, locally advanced or metastatic non-small cell lung cancer (NSCLC).
Approval summary: Docetaxel in combination with prednisone for the treatment of androgen-independent hormone-refractory prostate cancer. [2018]Docetaxel, a taxane previously approved for the treatment of breast cancer and non-small cell lung cancer, was approved by the United States Food and Drug Administration on May 19, 2004 for use in combination with prednisone for the treatment of metastatic androgen-independent (hormone-refractory) prostate cancer. The purpose of this summary is to review the database supporting this approval.
Docetaxel (Taxotere) in combination chemotherapy and in association with thoracic radiotherapy for the treatment of non-small-cell lung cancer. Thoracic Oncology Program. [2022]Docetaxel is one of the most active single agents for the treatment of non-small-cell lung cancer. Given the preclinical indications for synergy and the lack of cross-resistance with other active agents in this disease, clinical trials of docetaxel combinations have been undertaken. Phase I and II clinical trials of docetaxel in combination with cisplatin, carboplatin, gemcitabine, vinorelbine, or thoracic radiation for patients with non-small-cell lung cancer were reviewed. The endpoint for phase I trials was to define the phase II doses for the docetaxel combinations where overall response rates, median and one year survival were the endpoints. Five phase I-II studies of docetaxel and cisplatin have reported response rates ranging from 21% to 48%. Median survival times ranged from 8 to 13 months, and one-year survivals from 32% to 58%. Combining docetaxel with vinorelbine resulted in a 37% response rate and a median survival of 9.4 months. Docetaxel in combination with gemcitabine produced a response rate of 53%. The adverse events of these combinations were manageable. Responses have also been reported in studies of docetaxel administered with carboplatin or thoracic radiation therapy. Combinations of docetaxel with platinum, vinorelbine, gemcitabine, and radiation were active in non-small-cell lung cancer with acceptable adverse effects. Phase III trials are currently in progress to further define the role of docetaxel combinations in the first-line treatment of this disease.
Taxanes as first-line therapy for advanced non-small cell lung cancer: a systematic review and practice guideline. [2022]This evidence-based practice guideline on the use of paclitaxel (Taxol) or docetaxel (Taxotere) as first-line treatment for patients with advanced non-small cell lung cancer who are candidates for palliative first-line chemotherapy is based on a systematic search and review of literature published in full or in abstract form between 1985 and April 2005. Forty-five randomized trials, including 11 abstracts, were reviewed and clinicians in the province of Ontario, Canada, provided feedback on a draft version of the guideline. Two phase III trials detected a statistically significant survival advantage for a taxane (paclitaxel or docetaxel) with best supportive care versus best supportive care alone. Among the nine fully published phase III trials comparing platinum-based chemotherapies, taxane-platinum combinations achieved higher response rates compared with older chemotherapy combinations, although significantly longer survival was observed only for docetaxel-cisplatin compared with vindesine-cisplatin. Response rates and survival were generally not significantly different for taxane-platinum combinations compared with other current chemotherapy combinations, although the toxicity profile of the regimens varied. However, in one large trial, improved tumor response and modest survival and quality of life benefits were associated with docetaxel-cisplatin compared with vinorelbine-cisplatin. No statistically significant survival differences were detected in the three fully published phase III trials comparing a taxane-gemcitabine combination with a taxane-platinum regimen.