Clinical trial · Interventional
Study of NOV-002 in Combination With Chemotherapy to Treat Lung Cancer
Phase 3 Trial, Randomized, Open-Label, of NOV-002 in Combination With Paclitaxel and Carboplatin vs. Paclitaxel and Carboplatin Alone for the Treatment of Advanced Non-Small-Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this clinical trial is to find out whether or not the combination of NOV-002 with chemotherapy (paclitaxel and carboplatin) is better at improving overall survival time when compared to chemotherapy alone in people with non-small cell lung cancer (NSCLC). Earlier clinical trials in NSCLC showed that patients treated with NOV-002 in combination with chemotherapy had a better response (their tumors got smaller in one United States Phase 1/2 trial) than patients who received chemotherapy alone; and in two Phase 2 trials done in Russian patients, at the end of one year, patients treated with NOV-002 with chemotherapy had a better survival rate than patients who did not receive NOV-002 with their chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| NOV-002 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A: NOV-002 plus Chemotherapy
- description
- NOV-002 in combination with Paclitaxel and Carboplatin
- interventionNames
- Drug: Paclitaxel
- Drug: NOV-002
- Drug: Carboplatin
- type
- ACTIVE_COMPARATOR
- label
- Group B: Chemotherapy Alone
- description
- Paclitaxel and Carboplatin
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Overall survival during the length of the trial, length of the trial is approximately two years after last patient in
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Stage IIIb with malignant pleural or pericardial effusion or Stage IV (American Joint Committee on Cancer \[AJCC\]) NSCLC * ECOG performance score of 0 or 1 * Adequate bone marrow, hepatic, and renal function * New York Heart Association (NYHA) score 1-2 * Life expectancy of at least 12 weeks * Women of child-bearing potential and men whose partners are of child-bearing potential must be willing to use an acceptable method of birth control during trial participation or are surgically sterile or women who are post-menopausal (defined as not having a menstrual cycle for greater than two years). * The patient or patient's legal representative has the ability to understand the requirements of the trial, has provided written informed consent, and agrees to abide by the trial restrictions and to return for the required assessments. * The patient must be able to self administer daily subcutaneous injections or his/her caregiver must be able to administer daily subcutaneous injections. Exclusion Criteria: * Prior chemotherapy for advanced NSCLC or the patient has received prior neoadjuvant or adjuvant chemotherapy for NSCLC in the year prior to the date of randomization * Patients with central nervous system (CNS) metastases * Any systemic disease precluding chemotherapy * Chronic use of systemic corticosteroids in pharmacological doses * Known or history of HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Contraindication to treatment with paclitaxel or carboplatin or any of the components of NOV-002 * Any known preexisting medical condition, including substance abuse, that could interfere with the patient's participation in and completion of the protocol * Have received any investigational drug, defined as a drug for which there is no Food and Drug Administration (FDA) approved indication, within the 30 days prior to randomization * Pregnant female or nursing mother
References
Publications (0)
Data not yet available