18 and older, any sex, with Squamous Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Confirmed Best Objective Response (BOR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 Assessed by InvestigatorPrimary· Time from the first dose of study drug until occurrence of PD, death due to any cause (assessed up to 612 days)
Confirmed BOR was defined as the percentage of participants who achieved confirmed complete responses (CR) or partial response (PR), according to RECIST version 1.1 assessed by the Investigator.CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)= Neither sufficient increase to qualify for progression of disease (PD) nor sufficient shrinkage to qualify for PR. PD: At least a 20 % increase in the SLD, taking as reference the smallest SLD recorded from b
Group
Value
95% CI
Avelumab and Cetuximab
34.9
21.0 – 50.9
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (AEs), Treatment-Related Grade >=3 TEAEs and Immune-related Treatment Emergent AEs (irTEAEs)Secondary· Time from the first dose of study drug assessed up to (941 days)
Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug.Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE
TEAEs
Group
Value
95% CI
Avelumab and Cetuximab
41
Treatment-Related AEs
Group
Value
95% CI
Avelumab and Cetuximab
38
Treatment Related Grade>=3 TEAEs
Group
Value
95% CI
Avelumab and Cetuximab
24
irTEAEs
Group
Value
95% CI
Avelumab and Cetuximab
13
Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1Secondary· Time from the first dose of study drug until occurrence of PD, death due to any cause (assessed up to 737 days)
Progression free survival (PFS) is defined as the time (in months) from first treatment day to the date of the first documentation of objective progression of disease (PD) according to RECIST version 1.1 assessed by Investigator, or death due to any cause, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Group
Value
95% CI
Avelumab and Cetuximab
6.1
4.3 – 9.0
Duration of Response (DOR)Secondary· Time from the first dose of study drug until occurrence of PD, death due to any cause or last tumor assessment (assessed up to 612 days)
DOR is defined for participants with confirmed complete response (CR) or partial response (PR), as the time from first documentation of confirmed response to the date of first documentation of progression of disease (PD) according to RECIST version 1.1 (assessed by Investigator) or death due to any cause or tumor assessment. Duration of objective response was assessed using Kaplan-Meier analysis. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the SLD of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as ref
Group
Value
95% CI
Avelumab and Cetuximab
7.1
4.2 – 12.5
Immediate Observed Serum Concentration at End of Infusion (Ceoi) of AvelumabSecondary· Pre-dose, 2 hours after end of infusion on Day 1, 8, 22 and 29; Pre-dose, 30 minutes after the end of infusion on Day 43, 50, 64, 71; Pre-dose, 3 hours after end of infusion on Day 85, 99, 113, 127, 169, 253, and 337
Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed Avelumab concentration-time data.
Day 1
Group
Value
95% CI
Avelumab and Cetuximab
206
± 26.6
Day 8
Group
Value
95% CI
Avelumab and Cetuximab
243
± 23.8
Day 22
Group
Value
95% CI
Avelumab and Cetuximab
234
± 24.1
Day 29
Group
Value
95% CI
Avelumab and Cetuximab
282
± 26.8
Day 43
Group
Value
95% CI
Avelumab and Cetuximab
237
± 30.5
Day 50
Group
Value
95% CI
Avelumab and Cetuximab
259
± 38.9
Day 64
Group
Value
95% CI
Avelumab and Cetuximab
214
± 67.6
Day 71
Group
Value
95% CI
Avelumab and Cetuximab
244
± 43.8
Immediate Observed Serum Concentration at End of Infusion (Ceoi) of CetuximabSecondary· Pre-dose, 2 hours after end of infusion on Day 1, 8, 22 and 29; Pre-dose, 30 minutes after the end of infusion on Day 43, 50, 64, 71; Pre-dose, 3 hours after end of infusion on Day 85, 99, 113, 127, 169, 253, and 337
Ceoi is the serum concentration observed immediately at the end of infusion. This was taken directly from the observed cetuximab concentration-time data.
Day 1
Group
Value
95% CI
Avelumab and Cetuximab
109
± 50.7
Day 8
Group
Value
95% CI
Avelumab and Cetuximab
198
± 86.6
Day 22
Group
Value
95% CI
Avelumab and Cetuximab
124
± 54.4
Day 29
Group
Value
95% CI
Avelumab and Cetuximab
260
± 25.0
Day 43
Group
Value
95% CI
Avelumab and Cetuximab
154
± 32.7
Day 50
Group
Value
95% CI
Avelumab and Cetuximab
238
± 28.9
Day 64
Group
Value
95% CI
Avelumab and Cetuximab
159
± 36.1
Day 71
Group
Value
95% CI
Avelumab and Cetuximab
262
± 25.1
Serum Trough Concentration Levels (Ctrough) of AvelumabSecondary· Pre-dose: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 99, Day 113, Day 127, Day 169, Day 253 and Day 337
Ctrough is the serum concentration observed immediately before next dosing.
Day 8
Group
Value
95% CI
Avelumab and Cetuximab
28.8
± 82.7
Day 22
Group
Value
95% CI
Avelumab and Cetuximab
13.6
± 97.1
Day 29
Group
Value
95% CI
Avelumab and Cetuximab
42.4
± 147.8
Day 43
Group
Value
95% CI
Avelumab and Cetuximab
15.6
± 115.1
Day 50
Group
Value
95% CI
Avelumab and Cetuximab
56.4
± 77.9
Day 64
Group
Value
95% CI
Avelumab and Cetuximab
19.7
± 145.7
Day 71
Group
Value
95% CI
Avelumab and Cetuximab
58.2
± 62.5
Day 85
Group
Value
95% CI
Avelumab and Cetuximab
21.5
± 70.9
Serum Trough Concentration Levels (Ctrough) of CetuximabSecondary· Pre-dose: Day 8, Day 22, Day 29, Day 43, Day 50, Day 64, Day 71, Day 85, Day 99, Day 113, Day 127, Day 169, Day 253 and Day 337
Ctrough is the serum concentration observed immediately before next dosing.
Day 8
Group
Value
95% CI
Avelumab and Cetuximab
12.1
± 90.0
Day 22
Group
Value
95% CI
Avelumab and Cetuximab
12.8
± 63.7
Day 29
Group
Value
95% CI
Avelumab and Cetuximab
22.8
± 73.3
Day 43
Group
Value
95% CI
Avelumab and Cetuximab
25.6
± 103.7
Day 50
Group
Value
95% CI
Avelumab and Cetuximab
23.9
± 118.1
Day 64
Group
Value
95% CI
Avelumab and Cetuximab
17.2
± 157.9
Day 71
Group
Value
95% CI
Avelumab and Cetuximab
35.4
± 110.4
Day 85
Group
Value
95% CI
Avelumab and Cetuximab
26.5
± 119.4
Overall Survival (OS)Secondary· Time from the first dose of study drug until occurrence of death due to any cause (assessed up to 941 days)
OS is defined as the time from the first treatment day to the date of death due to any cause. Overall survival was assessed using Kaplan-Meier analysis.
Group
Value
95% CI
Avelumab and Cetuximab
10.1
8.6 – 14.5
Number of Participants With Positive Anti-Drug Antibody (ADA) of AvelumabSecondary· Pre-dose up to 149 days
The detection of antibodies to avelumab was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of avelumab were reported.
Group
Value
95% CI
Avelumab and Cetuximab
7
Number of Participants With Positive Anti-Drug Antibody (ADA) of CetuximabSecondary· Pre-dose up to 149 days
The detection of antibodies to cetuximab was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive anti-drug antibody (ADA) of cetuximab were reported.
Group
Value
95% CI
Avelumab and Cetuximab
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Time from the first dose of study drug until 941 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of the study was to investigate the clinical activity and safety of avelumab in combination with cetuximab plus gemcitabine and cisplatin in participants with treatment-naïve advanced squamous non-small-cell lung cancer (NSCLC).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06939036 — Study of 225Ac-SS0110 in Subjects With ES-SCLC or MCC (SANTANA-225 )
· Phase 1, PHASE2
· terminated
NCT05687721 — Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
· Phase 1, PHASE2
· withdrawn
NCT06518564 — Avelumab and M1774 in ARID1A-mutated Endometrial Cancer
· Phase 2
· recruiting
NCT06424717 — Study of Avelumab and Tuvusertib in Participants With Advanced Urothelial Cancer That Has Progressed on Prior Anti-PD-(L
· Phase 2
· withdrawn
NCT06302426 — Trial of INI-4001 in Patients With Advanced Solid Tumours
· Phase 1
· recruiting
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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 Merck KGaA, Darmstadt, Germany
Last refreshed: 6 June 2022
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/NCT03717155.