Evidence map›Paper›PMID 19287371›Full record

Trial reportCancer gene therapy2009

Phase II trial of Belagenpumatucel-L, a TGF-beta2 antisense gene modified allogeneic tumor vaccine in advanced non small cell lung cancer (NSCLC) patients.

J Nemunaitis, M Nemunaitis, N Senzer, P Snitz, C Bedell, P Kumar, B Pappen, P B Maples, D Shawler, H Fakhrai

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Cancer gene therapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00676507 (Phase III Study of Lucanix™), which is not on this map. Cited by 74 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 2 pooled it
4.0field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00676507 phase3completednot on this map

Phase III Study of Lucanix™ (Belagenpumatucel-L) in Advanced Non-small Cell Lung Cancer: An International Multicenter, Randomized, Double-blinded, Placebo-controlled Study of Lucanix™ Maintenance Therapy for Stages III/IV NSCLC Subjects Who Have Responded to or Have Stable Disease Following One Regimen of Front-line, Platinum-based Combination Chemotherapy

TypeinterventionalSponsorNovaRx CorporationRan2008 to 2013Enrolled532ConditionsLung Neoplasm, Carcinoma Non-small Cell Lung Cancer Stage IIIA, Carcinoma Non-small Cell Lung Cancer Stage IIIB, Carcinoma Non-small Cell Lung Cancer Stage IVArmsLucanix™, Placebo Comparator
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 2 syntheses or guidelines pooled it, 146 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. The next generation of immunotherapies for lung cancers.Nature reviews. Clinical oncology · 2025
    Review
  4. Review
  5. The progress of tumor vaccines clinical trials in non-small cell lung cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Review
  6. Therapeutic Vaccination in Lung Cancer: Past Attempts, Current Approaches and Future Promises.Journal of respiratory biology and translational medicine · 2025
    Article
  7. Review
  8. Review
  9. Review
  10. [Research Progress of Lung Cancer Vaccines].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2023
    Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Development of Cancer Immunotherapies.Cancer treatment and research · 2022
    Article

14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

J NemunaitisMary Crowley Cancer Research Centers, Dallas, TX 75201, USA. jnemunaitis@marycrowley.org
M Nemunaitis
N Senzer
P Snitz
C Bedell
P Kumar
B Pappen
P B Maples
D Shawler
H Fakhrai
Mary Crowley Cancer Research Center · USGradalis (United States) · USNovaRx (United States) · USTexas Oncology · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In a previous dose escalation trial we demonstrated dose related survival correlation to Belagenpumatucel-L. In order to further evaluate safety and response at the previously defined optimal dose and schedule and to gain preliminary evidence on a hypothesis that the level of circulating tumor cells (CTCs) in blood may correlate with the overall survival of patients with stage IV NSCLC, we initiated a phase II trial. Patients received intradermal immunization of 2.5 x 10(7) transfected allogeneic tumor cells (Belagenpumatucel-L, supplied by NovaRx) 1 x every month for a total of 16 months. Circulating tumor cells (Veridex, Raritan, NJ) were measured every 4 weeks. Twenty-one advanced NSCLC patients were enrolled on this study. No significant toxic effect was observed. Overall survival was 562 days. The median survival was 660 days in patients having less than 2 CTCs at baseline compared to 150 days in patients with 2 or more CTCs (P=0.025). Phase II results of safety and response are consistent with prior experience following treatment with Belagenpumatucel-L and there is a suggestion that the number of circulating tumor cells at baseline appears to correlate with overall survival. A larger clinical trial is warranted to further explore this observation.

Indexed as

AdultAgedCancer VaccinesCarcinoma, Non-Small-Cell LungDisease ProgressionDNA, AntisenseDose-Response Relationship, DrugFemaleGenetic TherapyHumansInjections, IntradermalLung NeoplasmsMaleMiddle AgedTransforming Growth Factor beta2Tumor Cells, Culturedbelagenpumatucel LCancer VaccinesDNA, AntisenseTransforming Growth Factor beta2

Identifiers

PMID19287371
OpenAlexW1993615391

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.