Volrustomig Priming Regimens Exploratory Phase II Platform Study

Last updated: February 19, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

Ramucirumab

Volrustomig

Pemetrexed

Clinical Study ID

NCT06448754
D798KC00001
2023-509482-20
2023-509482-20-00
  • Ages 18-130
  • All Genders

Study Summary

Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with nodeterioration.

  • Life expectancy greater than or equal to (>=) 12 weeks.

  • Adequate organ and bone marrow function.

  • Body weight greater than (>) 35 kilograms (kg) at screening and at randomization.

  • Histologically or cytologically documented NSQ NSCLC in substudy 1 and SQ or NSQmNSCLC in substudy 2.

  • Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.

  • Absence of documented tumor genomic alteration results from tests conducted as partof standard local practice in any other actionable driver oncogenes for which thereare locally approved targeted 1L therapies.

  • At least one measurable lesion not previously irradiated that can be accuratelymeasured at baseline as >= 10 millimeter (mm) in the longest diameter.

Exclusion

Key Exclusion Criteria:

  • Spinal cord compression.

  • History of primary active immunodeficiency.

  • Active or prior documented autoimmune or inflammatory disorders.

  • Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.

  • Brain metastases unless asymptomatic, stable, and not requiring steroids for atleast 14 days prior to start of study intervention. A minimum of 2 weeks must haveelapsed between the end of radiation therapy and study enrollment.

  • Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participantswho have received prior platinum-containing adjuvant, neoadjuvant, or definitivechemoradiation for local disease are eligible, provided that progression hasoccurred greater (>) 12 months from end of last therapy.

Study Design

Total Participants: 180
Treatment Group(s): 5
Primary Treatment: Ramucirumab
Phase: 2
Study Start date:
August 27, 2024
Estimated Completion Date:
July 30, 2027

Study Description

This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types.

This platform study currently includes 2 substudies:

Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous [NSQ]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B.

Substudy 2: mNSCLC (squamous [SQ] or NSQ). Participants will enroll to the Arm 2A only.

All arms will test a volrustomig dosing in combination with chemotherapy.

Connect with a study center

  • Research Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Montreal 6077243, Quebec 6115047 H4A 3J1
    Canada

    Site Not Available

  • Research Site

    Beijing, 100730
    China

    Site Not Available

  • Research Site

    Beijing 1816670, 100730
    China

    Active - Recruiting

  • Research Site

    Hangzhou, 310014
    China

    Site Not Available

  • Research Site

    Hangzhou 1808926, 310014
    China

    Active - Recruiting

  • Research Site

    Jinan, 250013
    China

    Site Not Available

  • Research Site

    Jinan 1805753, 250013
    China

    Active - Recruiting

  • Research Site

    Yantai, 264000
    China

    Site Not Available

  • Research Site

    Yantai 1787093, 264000
    China

    Active - Recruiting

  • Research Site

    Zhengzhou 1784658, 450000
    China

    Active - Recruiting

  • Research Site

    Zhengzhou City, 450000
    China

    Site Not Available

  • Research Site

    Bois Guillaume, 76031
    France

    Site Not Available

  • Research Site

    Bois-Guillaume 3032025, 76031
    France

    Active - Recruiting

  • Research Site

    Caen 3029241, 14076
    France

    Active - Recruiting

  • Research Site

    Caen Cedex, 14076
    France

    Site Not Available

  • Research Site

    Créteil, 94000
    France

    Site Not Available

  • Research Site

    Créteil 3022530, 94000
    France

    Site Not Available

  • Research Site

    Dijon, 21079
    France

    Site Not Available

  • Research Site

    Dijon 3021372, 21079
    France

    Active - Recruiting

  • Research Site

    Montpellier, 34070
    France

    Site Not Available

  • Research Site

    Montpellier 2992166, 34070
    France

    Active - Recruiting

  • Research Site

    Batumi, 6010
    Georgia

    Site Not Available

  • Research Site

    Batumi 615532, 6010
    Georgia

    Active - Recruiting

  • Research Site

    Tbilisi, 186
    Georgia

    Site Not Available

  • Research Site

    Tbilisi 611717, '0159
    Georgia

    Active - Recruiting

  • Research Site

    Athens, 12462
    Greece

    Site Not Available

  • Research Site

    Athens 264371, 115 27
    Greece

    Site Not Available

  • Research Site

    Elaiones, 546 23
    Greece

    Active - Recruiting

  • Research Site

    Peiraias, 185 47
    Greece

    Site Not Available

  • Research Site

    Piraeus 255274, 185 47
    Greece

    Active - Recruiting

  • Research Site

    Thessaloniki, 57001
    Greece

    Site Not Available

  • Research Site

    Thessaloniki 734077, 57001
    Greece

    Active - Recruiting

  • Research Site

    Genoa, 16132
    Italy

    Site Not Available

  • Research Site

    Genoa 3176219, 16132
    Italy

    Active - Recruiting

  • Research Site

    Meldola, 47014
    Italy

    Site Not Available

  • Research Site

    Meldola 3173635, 47014
    Italy

    Active - Recruiting

  • Research Site

    Milan 6951411, 20133
    Italy

    Active - Recruiting

  • Research Site

    Milano, 20133
    Italy

    Site Not Available

  • Research Site

    Napoli, 80131
    Italy

    Site Not Available

  • Research Site

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Research Site

    Orbassano, 10043
    Italy

    Site Not Available

  • Research Site

    Orbassano 3171986, 10043
    Italy

    Active - Recruiting

  • Research Site

    Perugia, 06132
    Italy

    Site Not Available

  • Research Site

    Perugia 3171180, 06132
    Italy

    Active - Recruiting

  • Research Site

    Rozzano, 20089
    Italy

    Site Not Available

  • Research Site

    Rozzano 3168837, 20089
    Italy

    Active - Recruiting

  • Research Site

    Udine, 33100
    Italy

    Site Not Available

  • Research Site

    Udine 3165072, 33100
    Italy

    Active - Recruiting

  • Research Site

    Verona, 37134
    Italy

    Site Not Available

  • Research Site

    Verona 3164527, 37134
    Italy

    Active - Recruiting

  • Research Site

    Seongnam, 13620
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Research Site

    Suwon, 16247
    Korea, Republic of

    Site Not Available

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Research Site

    Kuala Lumpur 1735161, 59100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuching, 93586
    Malaysia

    Site Not Available

  • Research Site

    Kuching 1735634, 93586
    Malaysia

    Active - Recruiting

  • Research Site

    Perai, 13700
    Malaysia

    Site Not Available

  • Research Site

    Perai 1735077, 13700
    Malaysia

    Active - Recruiting

  • Research Site

    Lisboa, 1400-038
    Portugal

    Site Not Available

  • Research Site

    Lisbon 2267057, 1400-038
    Portugal

    Active - Recruiting

  • Research Site

    Porto, 4100-180
    Portugal

    Site Not Available

  • Research Site

    Porto 2735943, 4100-180
    Portugal

    Site Not Available

  • Research Site

    Cluj-Napoca, 400641
    Romania

    Site Not Available

  • Research Site

    Cluj-Napoca 681290, 400641
    Romania

    Active - Recruiting

  • Research Site

    Craiova, 200542
    Romania

    Site Not Available

  • Research Site

    Craiova 680332, 200542
    Romania

    Active - Recruiting

  • Research Site

    Floresti, 407280
    Romania

    Site Not Available

  • Research Site

    Floreşti 678063, 407280
    Romania

    Active - Recruiting

  • Research Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Research Site

    Belgrade 792680, 11000
    Serbia

    Site Not Available

  • Research Site

    Kamenitz 3190104, 21204
    Serbia

    Active - Recruiting

  • Research Site

    Kragujevac, 34000
    Serbia

    Site Not Available

  • Research Site

    Kragujevac 789128, 34000
    Serbia

    Active - Recruiting

  • Research Site

    Sremska Kamenica, 21204
    Serbia

    Site Not Available

  • Research Site

    Seongnam 6876792, 13620
    South Korea

    Completed

  • Research Site

    Seoul 1835848, 06591
    South Korea

    Active - Recruiting

  • Research Site

    Suwon 1835553, 16247
    South Korea

    Active - Recruiting

  • Research Site

    A Coruña, 15009
    Spain

    Site Not Available

  • Research Site

    A Coruña 3119841, 15009
    Spain

    Active - Recruiting

  • Research Site

    Alcorcón, 28922
    Spain

    Site Not Available

  • Research Site

    Alcorcón 3130564, 28922
    Spain

    Active - Recruiting

  • Research Site

    Barcelona, 08041
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08041
    Spain

    Active - Recruiting

  • Research Site

    La Coruna, 15006
    Spain

    Site Not Available

  • Research Site

    Madrid, 28041
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • Research Site

    Málaga, 29004
    Spain

    Site Not Available

  • Research Site

    Málaga 2514256, 29004
    Spain

    Active - Recruiting

  • Research Site

    Pamplona, 31008
    Spain

    Site Not Available

  • Research Site

    Pamplona 3114472, 31008
    Spain

    Active - Recruiting

  • Research Site

    Santander, 39008
    Spain

    Site Not Available

  • Research Site

    Santander 3109718, 39008
    Spain

    Active - Recruiting

  • Research Site

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Research Site

    Santiago de Compostela 3109642, 15706
    Spain

    Active - Recruiting

  • Research Site

    Valencia, 46026
    Spain

    Site Not Available

  • Research Site

    Valencia 2509954, 46026
    Spain

    Active - Recruiting

  • Research Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Research Site

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • Research Site

    Geneva 2660646, 1205
    Switzerland

    Active - Recruiting

  • Research Site

    Genève 14, 1205
    Switzerland

    Site Not Available

  • Research Site

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Research Site

    Lausanne 2659994, 1011
    Switzerland

    Active - Recruiting

  • Research Site

    Winterthur, 8401
    Switzerland

    Site Not Available

  • Research Site

    Winterthur 2657970, 8401
    Switzerland

    Active - Recruiting

  • Research Site

    Zurich 2657896, 8091
    Switzerland

    Active - Recruiting

  • Research Site

    Zürich, 8091
    Switzerland

    Site Not Available

  • Research Site

    Changhua 1993459, 50006
    Taiwan

    Active - Recruiting

  • Research Site

    Changhua City, 50006
    Taiwan

    Site Not Available

  • Research Site

    New Taipei, 23561
    Taiwan

    Site Not Available

  • Research Site

    New Taipei City 12908892, 23561
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 106
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 106
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 110
    Taiwan

    Site Not Available

  • Research Site

    Los Angeles, California 90067
    United States

    Site Not Available

  • Research Site

    Los Angeles 5368361, California 5332921 90067
    United States

    Active - Recruiting

  • Research Site

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Research Site

    Wheat Ridge, Colorado 80033
    United States

    Site Not Available

  • Research Site

    Grand Junction 5423573, Colorado 5417618 81501
    United States

    Active - Recruiting

  • Research Site

    Wheat Ridge 5443948, Colorado 5417618 80033
    United States

    Active - Recruiting

  • Research Site

    Baltimore, Maryland 21231
    United States

    Site Not Available

  • Research Site

    Baltimore 4347778, Maryland 4361885 21231
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Site

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Research Site

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Research Site

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Active - Recruiting

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Tacoma 5812944, Washington 5815135 98405
    United States

    Site Not Available

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