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NCT03386929: SPRING
Survival Prolongation by Rationale Innovative Genomics
Phase 1, PHASE2 trial testing Avelumab in Non-small Cell Lung Cancer Metastatic in 15 participants. Terminated before completion.
29 December 2022
Quick facts
| Lead sponsor | Worldwide Innovative Network Association |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 29 November 2017 |
| Primary completion | 29 December 2022 |
| Estimated completion | 29 December 2022 |
| Sites | 5 locations across Spain, United States, Israel, Luxembourg |
Drugs / interventions tested
- Avelumab (avelumab) — full drug profile →
- Axitinib — full drug profile →
- Palbociclib (Palbociclib) — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer Metastatic — all drugs for Non-small Cell Lung Cancer Metastatic →
- Non-small Cell Lung Cancer Stage IIIB — all drugs for Non-small Cell Lung Cancer Stage IIIB →
Sponsor
Worldwide Innovative Network Association
Who can join
18 and older, any sex, with Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Stage IIIB. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of Informed Consent through the follow-up period of 90 days after discontinuation of the study treatment, up to 4,5 years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (11 terms)
| Reaction | System | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|---|
| Infusion related reaction | General disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Disease progression | General disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| General physical health deterioration | General disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
Other adverse events (151 terms — click to expand)
| Reaction | System | Dose Level 1 | Dose Level 2 | Dose Level 3 |
|---|---|---|---|---|
| Activated partial thromboplastin time prolonged | Investigations | — | — | — |
| Proteinuria | Renal and urinary disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Pain | General disorders | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Weight decreased | Investigations | — | — | — |
| White blood cell count decreased | Investigations | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Hypothyroidism | Endocrine disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Leukocytosis | Blood and lymphatic system disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Dysphagia | Gastrointestinal disorders | — | — | — |
| Stomatitis | Gastrointestinal disorders | — | — | — |
| Chills | General disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Blood creatinine increased | Investigations | — | — | — |
| Gamma-Glutamyltransferase increased | Investigations | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | — | — | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — | — | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — | — | — |
Most-reported serious reactions: Infusion related reaction, Anaemia, Coronary artery disease, Disease progression, Fatigue, General physical health deterioration, Neutrophil count decreased, Breast cancer.
Data from ClinicalTrials.gov NCT03386929 adverse events section.
Sponsor's own description
Patients with advanced/metastatic non-small cell lung cancer (NSCLC) with no documented targetable alterations (Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) translocation, ROS1 mutation if available or MET exon 14 skipping mutation if available) will receive a tri-therapy associating avelumab, axitinib and palbociclib.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Synergistic effect of immune checkpoint blockade and anti-angiogenesis in cancer treatment.
Yi M, Jiao D, Qin S, Chu Q, et al · · 2019 · cited 487× · PMID 30925919 · DOI 10.1186/s12943-019-0974-6 -
Genomic and transcriptomic profiling expands precision cancer medicine: the WINTHER trial.
Rodon J, Soria JC, Berger R, Miller WH, et al · · 2019 · cited 435× · PMID 31011205 · DOI 10.1038/s41591-019-0424-4 -
CDK4 and CDK6 kinases: From basic science to cancer therapy.
Fassl A, Geng Y, Sicinski P. · · 2022 · cited 351× · PMID 35025636 · DOI 10.1126/science.abc1495 -
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3 -
Posttranslational Modifications of PD-L1 and Their Applications in Cancer Therapy.
Hsu JM, Li CW, Lai YJ, Hung MC. · · 2018 · cited 240× · PMID 30442814 · DOI 10.1158/0008-5472.can-18-1892 -
Anti-angiogenic Agents in Combination With Immune Checkpoint Inhibitors: A Promising Strategy for Cancer Treatment.
Song Y, Fu Y, Xie Q, Zhu B, et al · · 2020 · cited 198× · PMID 32983126 · DOI 10.3389/fimmu.2020.01956 -
Selective inhibition of CDK4/6: A safe and effective strategy for developing anticancer drugs.
Yuan K, Wang X, Dong H, Min W, et al · · 2021 · cited 103× · PMID 33532179 · DOI 10.1016/j.apsb.2020.05.001 -
Evolving landscape of PD-L2: bring new light to checkpoint immunotherapy.
Wang Y, Du J, Gao Z, Sun H, et al · · 2023 · cited 74× · PMID 36522474 · DOI 10.1038/s41416-022-02084-y
Verify or expand the search:
- PubMed search for NCT03386929
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Non-small Cell Lung Cancer Metastatic
Currently open trials in the same condition.
- NCT07292168 — A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Ex · Phase 1, PHASE2 · recruiting
- NCT06517953 — Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations · Phase 2 · recruiting
- NCT04563338 — An Exploratory Study of Atezolizumab and Bevacizumab in Hepatocellular Carcinoma and Non-Small Cell Lung Cancer With Liv · Phase 2 · active not recruiting
- NCT04836728 — Phase II Study of Chemotherapy and PD-1 Inhibitor Combination With Autologous CIK Cell Immunotherapy to Treat Lung Cance · Phase 2 · active not recruiting
- NCT04504071 — Dacomitinib in Lung Cancer With Uncommon EGFR Mutations · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03386929 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Worldwide Innovative Network Association
- Last refreshed: 18 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03386929.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing