Evidence map›Paper›PMID 35307972›Full record

ArticleCancer medicine2022

A WIN Consortium phase I study exploring avelumab, palbociclib, and axitinib in advanced non-small cell lung cancer.

Benjamin Solomon, Ana Callejo, Jair Bar, Guy Berchem, Lyudmila Bazhenova, Pierre Saintigny, Fanny Wunder, Jacques Raynaud, Nicolas Girard, J Jack Lee and 13 more

4 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.8field-weighted citation impact, top 5% 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.

NCT03386929 phase1 / phase2terminatednot on this map

A Proof of Concept Study to Explore Safety and Efficacy of Tri-therapy Approach in Advanced/Metastatic NSCLC and Retrospectively Assess the Ability of Integrated Genomics and Transcriptomics to Match Patients to the Combination

TypeinterventionalSponsorWorldwide Innovative Network AssociationRan2017 to 2022Enrolled15ConditionsNon-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIBArmsAvelumab, Axitinib, Palbociclib
NCT06109207 phase1unknown statusnot on this mapstarted 2023, after this paper: background citation

The Safety and Feasibility of Neoadjuvant Camrelizumab With Dalpiciclib for the Treatment of Resectable Head and Neck Squamous Cell Carcinoma:A Phase 1 Trial

TypeinterventionalSponsorWest China HospitalRan2023 to 2025Enrolled6ConditionsHead and Neck Squamous Cell CarcinomaArmsCamrelizumab, Dalpiciclib 100mg, Dalpiciclib 150mg
NCT06225921 phase1unknown statusnot on this mapstarted 2023, after this paper: background citation

The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma:A Phase 1 Trial

TypeinterventionalSponsorWest China HospitalRan2023 to 2025Enrolled6ConditionsEsophageal Squamous Cell CarcinomaArmsAdebrelimab, Dalpiciclib 100mg, Dalpiciclib 150mg
NCT06654297 phase1active not recruitingnot on this mapstarted 2024, after this paper: background citation

The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma:A Phase 1 Trial

TypeinterventionalSponsorWest China HospitalRan2024 to 2027Enrolled6ConditionsEsophageal Squamous Cell CarcinomaArmsCamrelizumab, Palbociclib(100mg), Palbociclib(125mg)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 25 citations in OpenAlex.

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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

23 authors at 11 institutions in 6 countries.

Benjamin SolomonAvera Cancer Institute, Sioux Falls, South Dakota, USA.ORCID 0000-0002-6014-1775
Ana CallejoVall d'Hebron Hospital Campus and Institute of Oncology (VHIO), Barcelona, Spain.
Jair BarChaim Sheba Medical Center, Tel Hashomer, Israel.
Guy BerchemCentre Hospitalier de Luxembourg, Luxembourg Institute of Health, Luxembourg City, Luxemburg.
Lyudmila BazhenovaUniversity of California San Diego, Moores Cancer Center, San Diego, California, USA.
Pierre SaintignyCentre Léon Bérard, Cancer Research Center of Lyon, University of Lyon, Lyon, France.
Fanny WunderWorldwide Innovative Network (WIN) Association - WIN Consortium, Villejuif, France.
Jacques RaynaudARC Foundation for cancer research, Villejuif, France.
Nicolas GirardInstitut Curie, Paris, France.
J Jack LeeThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Raed SulaimanAvera Cancer Institute, Sioux Falls, South Dakota, USA.
Bruce ProuseAvera Cancer Institute, Sioux Falls, South Dakota, USA.
Catherine BressonWorldwide Innovative Network (WIN) Association - WIN Consortium, Villejuif, France.ORCID 0000-0002-7523-849X
Hila VenturaBen-Gurion University of the Negev, Be'er Sheva, Israel.
Shai MagidiWorldwide Innovative Network (WIN) Association - WIN Consortium, Villejuif, France.
Eitan RubinBen-Gurion University of the Negev, Be'er Sheva, Israel.
Brandon YoungBowden Laboratory, Murrieta, California, USA.
Amir OnnChaim Sheba Medical Center, Tel Hashomer, Israel.
Brian Leyland-JonesWorldwide Innovative Network (WIN) Association - WIN Consortium, Villejuif, France.
Richard L SchilskyWorldwide Innovative Network (WIN) Association - WIN Consortium, Villejuif, France.
Vladimir LazarWorldwide Innovative Network (WIN) Association - WIN Consortium, Villejuif, France.
Enriqueta FelipVall d'Hebron Hospital Campus and Institute of Oncology (VHIO), Barcelona, Spain.
Razelle KurzrockUniversity of California San Diego, Moores Cancer Center, San Diego, California, USA.ORCID 0000-0003-4110-1214
Worldwide Universities Network · GBAvera Health · USBen-Gurion University of the Negev · ILSheba Medical Center · ILUniversity of California San Diego · USVall d'Hebron Hospital Universitari · ESCentre Hospitalier de Luxembourg · LUFondation ARC pour la Recherche sur le Cancer · FRInstitut Curie · FRThe University of Texas MD Anderson Cancer Center · USUniversité Claude Bernard Lyon 1 · FR

Funding

VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI DIANE M SIMEONE · 1985 to 2026
$124.9M
NCI NIH HHS P30 CA023100
6 · The paper itself

Abstract

backgroundThe Worldwide Innovative Network (WIN) Consortium has developed the Simplified Interventional Mapping System (SIMS) to better define the cancer molecular milieu based on genomics/transcriptomics from tumor and analogous normal tissue biopsies. SPRING is the first trial to assess a SIMS-based tri-therapy regimen in advanced non-small cell lung cancer (NSCLC).

methodsPatients with advanced NSCLC (no EGFR, ALK, or ROS1 alterations; PD-L1 unrestricted; ≤2 prior therapy lines) received avelumab, axitinib, and palbociclib (3 + 3 dose escalation design).

resultsFifteen patients were treated (five centers, four countries): six at each of dose levels 1 (DL1) and DL2; three at DL3. The most common ≥Grade 3 adverse events were neutropenia, hypertension, and fatigue. The recommended Phase II dose (RP2D) was DL1: avelumab 10 mg/kg IV q2weeks, axitinib 3 mg po bid, and palbociclib 75 mg po daily (7 days off/21 days on). Four patients (27%) achieved a partial response (PR) (progression-free survival [PFS]: 14, 24, 25 and 144+ weeks), including two after progression on pembrolizumab. Four patients attained stable disease (SD) that lasted ≥24 weeks: 24, 27, 29, and 64 weeks. At DL1 (RP2D), four of six patients (66%) achieved stable disease (SD) ≥6 months/PR (2 each). Responders included patients with no detectable PD-L1 expression and low tumor mutational burden.

conclusionsOverall, eight of 15 patients (53%) achieved clinical benefit (SD ≥ 24 weeks/PR) on the avelumab, axitinib, and palbociclib combination. This triplet showed antitumor activity in NSCLC, including in tumors post-pembrolizumab progression, and was active at the RP2D, which was well tolerated. NCT03386929 clinicaltrial.gov.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAxitinibB7-H1 AntigenHumansPiperazinesProtein-Tyrosine KinasesProto-Oncogene ProteinsPyridinesAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedavelumabAxitinibB7-H1 AntigenpalbociclibPiperazinesProtein-Tyrosine KinasesProto-Oncogene ProteinsPyridinesanti-PD-L1CDK4/6genomicsNSCLCphase ItranscriptomicsVEGFR

Identifiers

PMID35307972
PMCPMC9302335
OpenAlexW4220721699

What OpenQuestion holds

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LicenceCC BY
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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.