Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer (NSCLC) Stages IIIB/IV
A Phase II/III Trial to Assess the Safety, Immunogenicity and Preliminary Efficacy of Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine Administered to Patients With Non-Small-Cell Lung Cancer (NSCLC) After Receiving Conventional First Line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to inability of patient enrollment, decision taken to terminate in the interests of patients and later Malaysia is incorporated into global Phase 3 trial.
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the recombinant human EGF-rP64K/Montanide ISA 51 vaccine is safe, immunogenic and effective in the treatment of stage IIIb/IV non-small-cell lung cancer (NSCLC).
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 (NSCLC) Stage IIIb/IV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human rEGF-P64K/Montanide Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vaccine Group
- description
- Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
- interventionNames
- Biological: Recombinant Human rEGF-P64K/Montanide Vaccine
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Patients in this arm will only receive Best Supportive Care.
Primary outcomes (1)
- measure
- Survival
- timeFrame
- Two and a half years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who have signed the informed consent form. * Patients who are eighteen years of age or over with histologically or cytologically confirmed NSCLC in advanced stages IIIb or IV, not amenable to any attempt of curative chemo-radiotherapy and/or surgery. * Patients with measurable lesions, defined as those measurable at least in one dimension (refered to higher diameter) and with a diameter equal or higher 20 mm using conventional techniques (PET, CT scan, MRI, Rx) or equal or higher 10 mm using CT scan. * Patients who have finished their last cycle of chemotherapy and/or radiotherapy not less than 4 weeks prior to randomization and not more than 8 weeks. * Female patients of reproductive potential must have negative pregnancy tests. Those female volunteers admitted to the study must be using a reliable means of contraception such as tubal ligation, oral contraceptive or IUD. * ECOG status 0 to 2. * Patients with normal organ and bone marrow function, as defined by the parameters in accordance to that provided by the normal lab reference range. * Patients with no evidence of objective disease progression, 1 month after finishing first line chemotherapy as per RECIST. Exclusion Criteria: * Patients who are candidates for combined modality treatment. * Patients who are receiving immunosuppressive therapy including corticosteroids. * Patients who have received immunotherapy within the previous 3 months. * Patients who have participated in a clinical study within the previous 30 days. * Patients who may be allergic to any component of the vaccine. * Medical reasons considered by the investigators as disqualification from the study such as significant uncontrolled co-morbid disease or potential non-compliance with the protocol. * Patients bearing brain metastasis from the primary lung tumor. * Patients bearing a second primary tumor. * Patients showing progressive disease after finishing first line chemotherapy.
References
Publications (0)
Data not yet available